FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk
Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.
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 designation. Guidance requires that FDA Class I recalls receive a minimum severity score of 4. Although no incidents have been reported, the potential for reduced or absent energy output during high-voltage therapy in implantable cardioverter defibrillators justifies the Severe classification.
Plain-English summary
Medtronic Inc. has recalled certain ICD-VR VISIA AF S US/OUS DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall is due to a potential defect in the high-voltage feedthrough component used in these devices. The issue affects both devices currently implanted and those available in inventory.
The affected devices may experience reduced or no energy output during high-voltage therapy, typically 0-12 joules. This issue stems from a specific glassed feedthrough used in the manufacturing process.
A total of 194 units with this defect have been identified and distributed nationally and worldwide. Specific lot serial numbers associated with this recall have been identified by the manufacturer and are available from the FDA.
The recalled product
- Product
- ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- output-failure
- device-malfunction
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 00643169720787
- Lot Serial Numbers: BWV600051S
- BWV600052S
- BWV600078S
- BWV600079S
- BWV600010S
- BWV600094S
- BWV600024S
- BWV600027S
- BWV600031S
- BWV600032S
- BWV600041S
- BWV600042S
- BWV600043S
- BWV600044S
- BWV600045S
- BWV600046S
- BWV600047S
- BWV600068S
- BWV600069S
Distribution
Distributed nationwide across the United States.
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