Implantable Defibrillators May Have Reduced Energy Output During Therapy
Medtronic is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may produce reduced or no energy output during high-voltage therapy, potentially preventing treatment delivery.
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 indicates a serious health hazard (minimum score 4). The potential for reduced or no-energy output during critical therapy could be life-threatening, but no illnesses or deaths have been reported in the source documentation.
Plain-English summary
Medtronic Inc. is recalling approximately 6,525 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DVMC3D1. These devices deliver high-voltage therapy to treat life-threatening abnormal heart rhythms.
The devices may have a rare defect in a specific feedthrough component that could cause reduced or no-energy output during high-voltage therapy (typically 0 to 12 joules). This defect could prevent the device from delivering the energy needed to correct the patient's dangerous heart rhythm.
The affected devices have been distributed nationwide and worldwide. Patients who have received one of these devices should contact their healthcare provider or Medtronic to discuss their individual situation. Do not make changes to heart medications or device settings without first consulting your doctor.
The recalled product
- Product
- ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-output
- 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 00643169837775
- Lot Serial Numbers: CWF606066S
- CWF601772S
- CWF604835S
- CWF604967S
- CWF605332S
- CWF601390S
- CWF603522S
- CWF602774S
- CWF605900S
- CWF600919S
- CWF600938S
- CWF601256S
- CWF601551S
- CWF601593S
- CWF601753S
- CWF601934S
- CWF601936S
- CWF602109S
- CWF602581S
Distribution
Distributed nationwide across the United States.
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