Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: RTK602501S, RTK602506S
- 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., Cardiac Rhythm and Heart Failure (CRHF)
- Reason for Recall:
- Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Product Codes/Lot Numbers:
Serial Numbers: RTK602501S, RTK602506S
Distribution:
Distributed in: US, GA, PA, NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0926-2021
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