Reported Jan 8, 2025 · Ongoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with…
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 CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
- Lot codes and dates
- GTIN00643169890961
- Serial Numbers
NPL1000442NPL1000448NPL1000453NPL1000765NPL1000776NPL1000797NPL1000809NPL1000810NPL1000811NPL1000813NPL1000814NPL1000815NPL1000817NPL1000818NPL1000819NPL1000827NPL1000830NPL1000834NPL1000835NPL1000858NPL1001552NPL1001558NPL1001564NPL1001566NPL1001574NPL1001583NPL1001590NPL1001591NPL1001592NPL1001594NPL1001595NPL1001601NPL1001608NPL1001615NPL1001620NPL1001629NPL1001630NPL1001631NPL1001650NPL1001651NPL1001656NPL1001670NPL1001675NPL1002257NPL1002259NPL1002260NPL1002264NPL1002265NPL1002266NPL1002267NPL1002281NPL1002282NPL1002284NPL1002286NPL1002288NPL1002295NPL1002297NPL1002308NPL1002309
- Amount recalled
- 59 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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