Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SM…

Recall date

November 21, 2024

Source

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

Recall number

Z-0774-2025

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 CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E