Medtronic Cardiac Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall on implanted cardiac devices with potential for therapy failure. Although no illnesses or injuries have been reported, the hazard classification reflects the serious nature of potential malfunction in a life-critical medical device.
Plain-English summary
Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DDMB1D1, manufactured with a specific feedthrough component may produce reduced or no energy output during high voltage (HV) therapy, typically in the 0–12 joules range. This is a rare potential defect affecting devices currently implanted in patients.
Approximately 22,484 units of the affected model have been distributed nationwide and worldwide. Patients who have received these devices should contact their healthcare provider to determine if their device is affected and to discuss appropriate management options.
The FDA has issued a Class I recall for this defect. Patients should not discontinue use of their devices without consulting their healthcare provider.
The recalled product
- Product
- ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169837713
- Lot Serial Numbers: CWA218162H
- CWA219897H
- CWA221224H
- CWA222730H
- CWA223319H
- CWA224001H
- CWA230660H
- CWA212204H
- CWA215507H
- CWA219655H
- CWA228049H
- CWA228101H
- CWA230635H
- CWA230642H
- CWA213967H
- CWA217145H
- CWA220168H
- CWA225093H
- CWA229346H
Distribution
Distributed nationwide across the United States.
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