Abiomed, Inc. recalls

31 recalls on record · latest: April 20, 2026

Official U.S. recall history for Abiomed, Inc., compiled from official government records.

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Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;

April 20, 2026 · Medical device recalls High risk A retrospective review identified that there are AIC units requiring specific h…

Abiomed, Inc. recalls Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configura…

February 18, 2026 · Medical device recalls High risk Increased risk of purge leaks with Generation 1 purge cassettes.

Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, P…

February 16, 2026 · Medical device recalls High risk Potential that the "Purge System Blocked" alarm display on the Automated Impell…

Abiomed, Inc. recalls Impella RP. Product Code: 0046-0011.

January 27, 2026 · Medical device recalls High risk Differential pressure (dP) sensor in Impella RP devices may malfunction, causin…

Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.

January 27, 2026 · Medical device recalls High risk Differential pressure (dP) sensor in Impella RP devices may malfunction, causin…

Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.

January 27, 2026 · Medical device recalls High risk Differential pressure (dP) sensor in Impella RP devices may malfunction, causin…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

December 4, 2025 · Medical device recalls Moderate risk Device packaged in incorrect outer box carton.

Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding…

October 1, 2025 · Medical device recalls High risk Potential cybersecurity vulnerabilities related to the operating system in the…

Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect…

September 16, 2025 · Medical device recalls High risk Potential for Automated Impella Controller (AIC) purge pressure issues due to p…

Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Con…

August 20, 2025 · Medical device recalls High risk Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit A…

Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controll…

June 23, 2025 · Medical device recalls High risk A potential issue with the Automated Impella Controller (AIC) not detecting an…

Abiomed, Inc. recalls Impella RP with SmartAssist; Product Number: 0046-0035;

December 12, 2024 · Medical device recalls High risk Optical Sensors have been damaged due to physical interaction between the inlet…

Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;

December 12, 2024 · Medical device recalls High risk Optical Sensors have been damaged due to physical interaction between the inlet…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 Set AU; Product Code: 1000361;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Pump 371 14F LT CMR Set; Product Code: 0048-0045;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Smart Assist Set; Product Code: 1000402;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Pump 381 Pump Set (US); Product Code: 1000080;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…

Abiomed, Inc. recalls ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

August 5, 2024 · Medical device recalls Moderate risk A potential device interaction between the Shockwave Coronary IVL Catheter and…