MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00763000611941, Serial Numbers: CWT611927S, CWT611929S, CWT611932S, CWT611933S, CWT611934S, CWT611935S, CWT611936S, CWT611937S, CWT611938S, CWT611939S, CWT611940S, CWT611941S, CWT611950S, CWT611951S, CWT612011S, CWT612012S, CWT612013S, CWT612014S, CWT612015S, CWT612016S, CWT612017S, CWT612022S, CWT612044S, CWT612045S; GTIN: 00763000740368, Serial Numbers: CWT611893S, CWT611908S.
- 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 DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Product Codes/Lot Numbers:
GTIN: 00763000611941, Serial Numbers: CWT611927S, CWT611929S, CWT611932S, CWT611933S, CWT611934S, CWT611935S, CWT611936S, CWT611937S, CWT611938S, CWT611939S, CWT611940S, CWT611941S, CWT611950S, CWT611951S, CWT612011S, CWT612012S, CWT612013S, CWT612014S, CWT612015S, CWT612016S, CWT612017S, CWT612022S, CWT612044S, CWT612045S; GTIN: 00763000740368, Serial Numbers: CWT611893S, CWT611908S.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2202-2024
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.