Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
- 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:
- The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Product Codes/Lot Numbers:
Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1650-2021
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