Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…

Recall date

November 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0771-2025

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Software issues were identified in application version 2.x.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B