Implantable Defibrillators May Produce Reduced or No Energy Output
Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed 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 classification establishes a minimum score of 4 (Severe) due to potential for serious adverse health consequences in a life-critical device. No injuries or deaths have been reported.
Plain-English summary
Medtronic is recalling 176 units of the ICD-VR VISIA AF S US/OUS IS1/DF1 implantable cardioverter defibrillators (Model DVAC3D1) due to a defect in the device's feedthrough component.
The defective feedthrough creates a rare potential for reduced or no-energy output during high voltage (HV) therapy, typically delivered at 0-12 joules. This malfunction could prevent the device from delivering the electrical therapy needed to treat abnormal heart rhythms.
The affected devices were distributed nationwide in the United States and worldwide.
The recalled product
- Product
- ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
- Hazard
- Affected units
- 176
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 00643169720770
- Lot Serial numbers: BWU600672S
- BWU600685S
- BWU600654S
- BWU600656S
- BWU600555S
- BWU600638S
- BWU600641S
- BWU600642S
- BWU600647S
- BWU600648S
- BWU600650S
- BWU600651S
- BWU600664S
- BWU600643S
- BWU600645S
- BWU600557S
- BWU600556S
- BWU600763S
- BWU600640S
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.
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