Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.
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. Although no illnesses or injuries have been reported, the potential for reduced or no energy output in implanted cardiac defibrillators during high voltage therapy could prevent necessary treatment in patients with life-threatening arrhythmias.
Plain-English summary
Medtronic Inc. has recalled certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. The affected model is the ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, with approximately 1,354 units involved in the recall.
There is a rare potential for these devices to produce reduced or no energy output during high voltage (0-12 joule) therapy. This could prevent the device from delivering necessary treatment when patients require life-saving defibrillation.
The recalled devices were distributed in the United States and internationally. Patients implanted with one of the potentially affected devices can consult the official FDA recall notice for the complete list of affected serial numbers and can contact their healthcare provider for evaluation.
The recalled product
- Product
- ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- 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 00643169218017
- Lot Serial numbers: BWK607537S
- BWK607358S
- BWK607401S
- BWK607460S
- BWK607496S
- BWK607540S
- BWK607351S
- BWK607371S
- BWK607254S
- BWK607394S
- BWK607446S
- BWK607457S
- BWK607473S
- BWK607498S
- BWK607503S
- BWK607536S
- BWK607381S
- BWK607393S
- BWK607369S
Distribution
Distributed nationwide across the United States.
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