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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 425
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.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
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- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- CriticalImplantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
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