🔍 RecallPedia

Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

Class I - Dangerous
🏥 Medical Devices Recalled: July 9, 2021 Medtronic Neuromodulation Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Neuromodulation
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

Product Codes/Lot Numbers:

a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2159-2021

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Medtronic Neuromodulation

Class I - Dangerous

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