Reported Aug 4, 2021 · Ongoing
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
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?
- Medtronic Vectris SureScan MRI
- Catalog Numbersa) 977A260 b) 977A275 c) 977A290
- Lot codes and dates
a) 977A260PIN 977A20024VUDI 00763000324353 b) 977A275PIN 977A20025VUDI 00763000324360 c) 977A290PIN 977A20028VUDI 00763000324377
- Amount recalled
- 1131 units
Why it was recalled
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
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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