Reported Jan 8, 2025 · Ongoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL…
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 CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
- Lot codes and dates
- GTIN00763000094027 00763000077730 00763000421007 00763000447090
- Serial Numbers
566 of 566 codes
NPL3000006NPL3000007NPL3000009NPL3000011NPL3000016NPL3000017NPL3000023NPL3000026NPL3000029NPL3000043NPL3000046NPL3000050NPL3000055NPL3000063NPL3000068NPL3000083NPL3000090NPL3000103NPL3000105NPL3000129NPL3000185NPL3000186NPL3000187NPL3000189NPL3000191NPL3000192NPL3000197NPL3000198NPL3000203NPL3000205NPL3000206NPL3000209NPL3000210NPL3000215NPL3000216NPL3000219NPL3000222NPL3000223NPL3000229NPL3000232NPL3000237NPL3000240NPL3000242NPL3000246NPL3000248NPL3000250NPL3000252NPL3000253NPL3000255NPL3000262NPL3000264NPL3002259NPL3002261NPL3002266NPL3002273NPL3002274NPL3002275NPL3002278NPL3002283NPL3002288
- Amount recalled
- 566 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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