MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00763000611972, Serial Numbers: CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, CWP605658S.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 Inc.
- Reason for Recall:
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Product Codes/Lot Numbers:
GTIN: 00763000611972, Serial Numbers: CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, CWP605658S.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2204-2024
Related Recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.