Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic recalls certain ICD and CRT-D defibrillators due to a rare potential for reduced or no-energy output during high-voltage therapy. Affected devices were manufactured with a specific glassed feedthrough component.
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 requires a minimum severity of 4. Although no illnesses have been reported and the defect is described as rare, the underlying hazard involves potential failure of critical lifesaving defibrillation therapy delivery.
Plain-English summary
Medtronic is recalling certain ICD-VR DVME3D1 MIRRO MRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high-voltage therapy. The devices were manufactured with a specific glassed feedthrough component that may be affected.
The defect may result in the device delivering insufficient or no energy during defibrillation therapy, which typically ranges from 0 to 12 joules. Approximately 3,852 units have been distributed nationwide and worldwide. The recall includes multiple serial number lots manufactured with the affected feedthrough design.
Patients with affected ICDs or CRT-Ds should contact their healthcare provider or Medtronic to determine if their device is part of this recall. Device identification can be confirmed by checking the serial number against the provided lot list. Do not discontinue use of your device without consulting your physician.
The recalled product
- Product
- ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-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 00763000001605
- Lot Serial Numbers: CWP603713S
- CWP601986S
- CWP600810S
- CWP602954S
- CWP602169S
- CWP602564S
- CWP602486S
- CWP601838S
- CWP600696S
- CWP602627S
- CWP602315S
- CWP602621S
- CWP604004S
- CWP603407S
- CWP603894S
- CWP604066S
- CWP602233S
- CWP603772S
- CWP603201S
Distribution
Distributed nationwide across the United States.
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