Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.
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 classification indicates reasonable probability of serious adverse health consequences. Device failure during critical therapy could prevent life-saving defibrillation, though no reported deaths or serious injuries are documented in the source material.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component. The FDA has classified this as a Class I recall.
The recalled devices may fail to deliver the necessary energy during high-voltage therapy (typically 0-12 joules), which is designed to treat dangerous heart rhythms. This failure could prevent the device from delivering life-saving defibrillation therapy during a cardiac emergency.
The recall affects 4 units with lot serial numbers BWH224619H, BWH224621H, BWH224620H, and BWH224623H. The devices have been distributed nationwide and worldwide.
Patients with these devices should contact their healthcare provider immediately. Your cardiologist can verify whether your device is part of this recall and discuss appropriate next steps.
The recalled product
- Product
- ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- device-malfunction
- defibrillation-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 (5)
- GTIN 00643169720435
- Lot Serial Number: BWH224619H
- BWH224621H
- BWH224620H
- BWH224623H
Distribution
Distributed nationwide across the United States.
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