Medtronic ICD-VR PRIMO MRI Defibrillators: Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators and CRT-Ds may fail to deliver adequate energy during high-voltage therapy due to a feedthrough component defect. This affects 5,215 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 recall; minimum severity score is 4. While no illnesses, injuries, or deaths have been reported, the potential for reduced or absent energy output in devices critical for managing life-threatening heart rhythms represents a serious safety concern.
Plain-English summary
Medtronic Inc. is recalling certain ICD-VR DVMD3D1 PRIMO MRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. The recall affects approximately 5,215 units distributed nationwide and worldwide.
There is a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12 joules) in the affected devices. These devices are used to treat dangerous cardiac arrhythmias through electrical therapy.
This defect could affect the device's ability to deliver critical therapy when needed. The issue affects both currently implanted devices and those available for implantation.
The recalled product
- Product
- ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- therapy-delivery-failure
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 00763000001520
- Lot Serial Numbers: CWK604305S
- CWK601554S
- CWK601693S
- CWK601762S
- CWK603310S
- CWK600674S
- CWK605298S
- CWK605119S
- CWK605216S
- CWK605052S
- CWK605244S
- CWK605024S
- CWK605176S
- CWK605108S
- CWK605326S
- CWK605015S
- CWK605215S
- CWK605100S
- CWK605123S
Distribution
Distributed nationwide across the United States.
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