Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a glassed feedthrough defect. The FDA Class I recall involves 240 units.
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 medical device recalls require a minimum severity score of 4 (Severe) per the rubric. The hazard involves potential failure of therapy delivery in a life-critical device; however, the source reports no deaths or confirmed injuries, so the score remains 4 rather than 5 (Critical).
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically the ICD-VR DVAB1D4 VISIA AF US DF4 model. These are implanted devices designed to deliver electrical therapy to correct dangerous heart rhythms.
The recalled devices may produce reduced or no energy output during high-voltage therapy (typically 0-12 joules) due to a defect in a specific glassed feedthrough component. This creates a rare potential for the device to fail to deliver the necessary electrical therapy.
The recall affects 240 units distributed nationwide in the United States and worldwide. Affected devices are identified by specific lot serial numbers.
The FDA classified this as a Class I recall due to the serious potential for therapy failure in a life-critical device. Patients with this device model should contact their healthcare provider or Medtronic to verify whether their device is affected.
The recalled product
- Product
- ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-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 00643169720626
- Lot Serial Numbers: BWP202537H
- BWP202379H
- BWP202439H
- BWP202454H
- BWP202474H
- BWP202510H
- BWP202522H
- BWP202523H
- BWP202252H
- BWP202639H
- BWP202514H
- BWP202179H
- BWP202398H
- BWP202399H
- BWP202554H
- BWP202420H
- BWP202447H
- BWP202494H
- BWP201863H
Distribution
Distributed nationwide across the United States.
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