Reported Jan 8, 2025 · Ongoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…
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 CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
- Lot codes and dates
- GTIN
0064316989094700763000447090
- Serial Numbers
319 of 319 codes
NPL1000037NPL1000042NPL1000045NPL1000048NPL1000051NPL1000054NPL1000055NPL1000056NPL1000062NPL1000069NPL1000072NPL1000073NPL1000074NPL1000075NPL1000078NPL1000083NPL1000092NPL1000093NPL1000094NPL1000096NPL1000098NPL1000132NPL1000151NPL1000159NPL1000161NPL1000165NPL1000166NPL1000173NPL1000174NPL1000179NPL1000180NPL1000185NPL1000186NPL1000189NPL1000191NPL1000195NPL1000196NPL1000230NPL1000233NPL1000238NPL1000239NPL1000249NPL1000257NPL1000281NPL1000297NPL1000301NPL1000303NPL1000321NPL1000323NPL1000325NPL1000331NPL1000334NPL1000343NPL1000344NPL1000361NPL1000363NPL1000367NPL1000370NPL1000486NPL1000501
- GTIN
- Amount recalled
- 319 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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