Reported Jan 8, 2025 · Ongoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- 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
- Lot codes and dates
- GTIN00763000447090 00763000729141 00763000737290 00763000447090
- Serial NumbersN
2,956 of 2,956 codes
NPL3020725NPL3021958NPL3021963NPL3021966NPL3021969NPL3021970NPL3021971NPL3021974NPL3021983NPL3021984NPL3021990NPL3021997NPL3022002NPL3022005NPL3022014NPL3022022NPL3022031NPL3022032NPL3022038NPL3022044NPL3022052NPL3022062NPL3022069NPL3022070NPL3022071NPL3022072NPL3022073NPL3022074NPL3022109NPL3022114NPL3022118NPL3022124NPL3022125NPL3022131NPL3022139NPL3022187NPL3022190NPL3022193NPL3022194NPL3022195NPL3022212NPL3022213NPL3022216NPL3022218NPL3022245NPL3022257NPL3022278NPL3022280NPL3022289NPL3022291NPL3022304NPL3022311NPL3022313NPL3022314NPL3022328NPL3022352NPL3022357NPL3022364NPL3022365NPL3022711
- Amount recalled
- 3981 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Software issues were identified in application version 2.x.
This product could cause temporary or reversible health problems — stop using it.
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