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) 977A260
    • PIN 977A20024V
    • UDI 00763000324353 b) 977A275
    • PIN 977A20025V
    • UDI 00763000324360 c) 977A290
    • PIN 977A20028V
    • UDI 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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:24 PM UTC

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