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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Medtronic Inc.: Cobalt XT DR MRI SureScan ICD Recalled for Battery Testing Failure

Agency Publication Date: January 22, 2024
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Summary

Medtronic Inc. is recalling one Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator (model DDPA2D1) because the device's battery may not have been properly screened for defects. During manufacturing, the battery was retested after failing a high-voltage test, which the testing system should not have allowed. This single affected device was distributed in Florida, and consumers should contact their doctor to determine if their implant is the one impacted.

Risk

A battery that fails quality testing but is then retested until it passes may have internal defects that compromise its reliability. If the battery fails while the device is implanted, it could cause the heart device to lose power suddenly, preventing it from delivering life-saving electrical therapy when needed.

What You Should Do

  1. Confirm if your device is the affected Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1, with Serial Number RSL604096S and UDI/DI 00763000178338.
  2. Since this is an implanted medical device, do not take any independent action to remove or disable the product.
  3. Immediately contact your cardiologist or healthcare provider to confirm if your specific implant is the affected unit and to discuss monitoring or replacement options.
  4. Contact Medtronic Inc. at their Mounds View, Minnesota office or through your medical provider for specific instructions regarding this recall.
  5. For further information or to report concerns, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider notification and potential replacement.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator
Model / REF:
DDPA2D1
UPC Codes:
00763000178338
Lot Numbers:
Serial Number RSL604096S

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93663
Status: Active
Manufacturer: Medtronic Inc.
Sold By: Hospitals; Cardiology Clinics
Manufactured In: United States
Units Affected: 1 device
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.