Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.
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: This is an FDA Class I recall, which establishes a minimum severity of 4 per the rubric. Although no deaths or illnesses have been reported, the potential consequence—failure of a life-critical cardiac device to deliver defibrillation therapy—is serious. Class I designation reflects the FDA's determination that the defect poses a serious risk to health.
Plain-English summary
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDMB2D1 EVERA MRI XT OUS DF1. The recall affects 8,626 units distributed nationwide and worldwide. These devices were manufactured with a specific feedthrough.
There is a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range. If such a failure occurs, the device would be unable to deliver the defibrillation therapy necessary to treat dangerous heart rhythms.
Patients with affected devices should contact their healthcare provider or Medtronic. Information to identify affected devices, including specific lot serial numbers, is available through the manufacturer and the FDA.
The recalled product
- Product
- ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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 00643169837720
- Lot Serial Numbers: CWB609778S
- CWB609784S
- CWB609523S
- CWB603432S
- CWB605718S
- CWB601752S
- CWB601945S
- CWB601946S
- CWB602803S
- CWB605225S
- CWB607387S
- CWB609714S
- CWB605552S
- CWB601729S
- CWB602371S
- CWB603105S
- CWB603660S
- CWB603852S
- CWB604726S
Distribution
Distributed nationwide across the United States.
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