Boston Scientific Corporation recalls

165 recalls on record · latest: March 30, 2026

Official U.S. recall history for Boston Scientific Corporation, compiled from official government records.

Get recall alerts

Free email alert whenever Boston Scientific Corporation has a new recall — straight from official government data. Unsubscribe anytime.

Boston Scientific Corporation recalls LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versi…

March 30, 2026 · Medical device recalls Moderate risk For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M31…

Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

March 30, 2026 · Medical device recalls Moderate risk For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M31…

Boston Scientific Corporation recalls Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled a…

March 19, 2026 · Medical device recalls High risk Updated software, Brady software maintenance release 6 (SMR6), is now available…

Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITU…

March 19, 2026 · Medical device recalls High risk Updated software, Brady software maintenance release 6 (SMR6), is now available…

Boston Scientific Corporation recalls EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

February 10, 2026 · Medical device recalls Moderate risk Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or com…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

December 19, 2025 · Medical device recalls High risk Increased reports of stent deployment and expansion issues. The most common out…

Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H7…

December 3, 2025 · Medical device recalls Moderate risk Boston Scientific is initiating the removal of certain batches of Coyote" Over-…

Boston Scientific Corporation recalls CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 7…

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3)…

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3)…

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls TENACIO Pump with InhibiZone; UPN: 72404429;

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls TENACIO Pump without InhibiZone; UPN: 72404420;

September 11, 2025 · Medical device recalls Moderate risk The potential for devices to experience inflation and/or deflation performance…

Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

August 28, 2025 · Medical device recalls Moderate risk The product in incorrectly labeled. The label indicates that the skive hole sho…

Boston Scientific Corporation recalls ACCOLADE DR SL MRI (Model L311)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number S722, ALTRUA 2 DR EL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls PROPONENT DR SL (Model L201)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls ACCOLADE SR SL MRI (Model L310)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L100, ESSENTIO SR SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number U125, VALITUDE CRT-P EL

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls ACCOLADE SR SL (Model L300)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L111, ESSENTIO DR SL MRI Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number S701 ALTRUA 2 SR SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls ACCOLADE DR EL (Model L321)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls ACCOLADE DR SL (Model L301)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L210 PROPONENT SR SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number U225 VISIONIST CRT-P EL

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L110, ESSENTIO SR SL MRI Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L121 ESSENTIO DR EL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls ACCOLADE DR EL MRI (Model L331)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L131, ESSENTIO DR EL MRI Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L221 PROPONENT DR EL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number U228, VISIONIST CRT-P EL MRI

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls PROPONENT SR SL (Model L200)

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number U226, VISIONIST CRT-P EL

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L209 PROPONENT DR (VDD) SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L101, ESSENTIO DR SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L231, PROPONENT DR EL MRI Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number U128, VALITUDE CRT-P EL MRI

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number S702, ALTRUA 2 DR SL Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker

August 20, 2025 · Medical device recalls High risk Software to enhance Safety Architecture is available and designed to prevent in…

Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

August 18, 2025 · Medical device recalls Moderate risk Certain desiccant tube subassemblies were built with end caps that were not cor…

Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-…

August 18, 2025 · Medical device recalls Moderate risk Certain desiccant tube subassemblies were built with end caps that were not cor…

Boston Scientific Encore Advantage Kit recalled over foreign material

August 5, 2025 · Medical device recalls Moderate risk The Encore 26 Inflation Device is used with balloon dilation catheters to creat…

Boston Scientific Encore 26 Inflation Device recalled over foreign material

August 5, 2025 · Medical device recalls Moderate risk The Encore 26 Inflation Device is used with balloon dilation catheters to creat…

Boston Scientific UroMax Ultra Kit recalled over foreign material

August 5, 2025 · Medical device recalls Moderate risk The Encore 26 Inflation Device is used with balloon dilation catheters to creat…

Boston Scientific NephroMax Kit recalled over foreign material

August 5, 2025 · Medical device recalls Moderate risk The Encore 26 Inflation Device is used with balloon dilation catheters to creat…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transsepta…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transsept…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transsepta…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal acc…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transsepta…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsept…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal…

July 29, 2025 · Medical device recalls High risk Boston Scientific has identified a higher likelihood of air embolism events whe…

Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 01…

July 24, 2025 · Medical device recalls High risk Affected lead models may experience gradually rising LVSI measurements in assoc…

Boston Scientific Corporation recalls RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Mod…

July 24, 2025 · Medical device recalls High risk Affected lead models may experience gradually rising LVSI measurements in assoc…

Boston Scientific Corporation recalls ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model…

July 24, 2025 · Medical device recalls High risk Affected lead models may experience gradually rising LVSI measurements in assoc…

Boston Scientific Corporation recalls Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material n…

July 7, 2025 · Medical device recalls High risk Certain batches are being removed due to an increase in complaints received in…

Boston Scientific Corporation recalls FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

June 25, 2025 · Medical device recalls Moderate risk The potentially impacted units were manufactured using specific equipment that…

Boston Scientific Corporation recalls VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHE…

June 10, 2025 · Medical device recalls Moderate risk Potential for hole in the Tyvek layer of the sterile barrier pouch, which may c…

Boston Scientific Corporation recalls VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device app…

June 10, 2025 · Medical device recalls Moderate risk Potential for hole in the Tyvek layer of the sterile barrier pouch, which may c…

Boston Scientific Corporation recalls VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF…

June 10, 2025 · Medical device recalls Moderate risk Potential for hole in the Tyvek layer of the sterile barrier pouch, which may c…

Boston Scientific Corporation recalls Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55…

June 10, 2025 · Medical device recalls Moderate risk Potential for hole in the Tyvek layer of the sterile barrier pouch, which may c…

Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure ga…

March 24, 2025 · Medical device recalls Moderate risk Boston Scientific has identified that IceSeedTM CX needles manufactured between…

Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure…

March 24, 2025 · Medical device recalls Moderate risk Boston Scientific has identified that IceSeedTM CX needles manufactured between…

Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g…

March 24, 2025 · Medical device recalls Moderate risk Boston Scientific has identified that IceSeedTM CX needles manufactured between…

Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure…

March 24, 2025 · Medical device recalls Moderate risk Boston Scientific has identified that IceSeedTM CX needles manufactured between…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

December 20, 2024 · Medical device recalls Moderate risk Reported Outer sheath distal black tip detaching from the device can remain aro…

Boston Scientific Corporation recalls ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific Corporation recalls VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific Corporation recalls ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Num…

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific Corporation recalls ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Nu…

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific Corporation recalls VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific Corporation recalls PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Num…

December 12, 2024 · Medical device recalls High risk A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built be…

Boston Scientific product recalled over labeling errors

October 28, 2024 · Medical device recalls Moderate risk Potential for mislabeled packaging in which a device labeled as a Pressure Regu…

AMS Artificial Urinary Sphincter Control Pump recalled over labeling errors

October 28, 2024 · Medical device recalls Moderate risk Potential for mislabeled packaging in which a device labeled as a Pressure Regu…

Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

October 10, 2024 · Medical device recalls High risk Boston Scientific is updating the instructions for use of their POLARx and POLA…