Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic implantable defibrillators with certain feedthroughs may fail to deliver high-voltage therapy when needed. This rare malfunction could prevent life-saving electrical treatment.
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 product received an FDA Class I classification, which mandates a minimum severity score of 4. The potential for reduced or absent electrical output in a life-critical implanted cardiac device represents a serious patient safety risk.
Plain-English summary
Medtronic Inc. is recalling 425 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DVAB1D1 VISIA AF, due to a manufacturing defect.
The recalled devices contain a specific type of feedthrough that may result in reduced or no electrical output during high-voltage therapy, typically 0-12J. This rare potential malfunction could prevent the device from delivering necessary therapy.
The affected devices were distributed nationwide and worldwide. Specific lot serial numbers are documented in the recall notice.
The recalled product
- Product
- ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-delivery-failure
- manufacturing-defect
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 00643169720619
- Lot Serial Numbers: BWN203363H
- BWN203588H
- BWN203428H
- BWN203504H
- BWN203530H
- BWN203214H
- BWN203258H
- BWN203259H
- BWN203304H
- BWN203477H
- BWN203665H
- BWN203423H
- BWN203403H
- BWN203327H
- BWN203518H
- BWN203790H
- BWN203174H
- BWN203624H
- BWN203750H
Distribution
Distributed nationwide across the United States.
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