Implantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.
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: FDA Class I classification establishes the minimum severity floor of 4 per the rubric. Although no patient illnesses or injuries have been reported, the potential for therapy delivery failure in an implanted cardiac device poses a serious risk.
Plain-English summary
Medtronic Inc. is recalling the ICD-VR VISIA AF XT OUS IS1/DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The devices have a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range, due to a specific glassed feedthrough component.
While this is a theoretical risk with no reported illnesses or injuries, the potential failure to deliver therapy during a cardiac event is serious. Affected patients should immediately contact their cardiologist or Medtronic to determine if their device is included in this recall.
The recall involves 71 units with specific lot serial numbers distributed nationwide and worldwide. Patients and healthcare providers should verify serial numbers against the FDA recall notice and follow Medtronic's instructions for device management.
The recalled product
- Product
- ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
- Affected units
- 71
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 00643169720756
- Lot Serial Numbers: BWR600821S
- BWR600947S
- BWR600936S
- BWR600937S
- BWR600941S
- BWR600946S
- BWR600959S
- BWR601046S
- BWR600938S
- BWR601096S
- BWR601093S
- BWR600979S
- BWR601092S
- BWR600997S
- BWR600934S
- BWR600965S
- BWR601050S
- BWR601049S
- BWR600823S
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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