Implantable Cardioverter Defibrillators with defective feedthrough may fail therapy delivery
Medtronic's EVERA XT implantable cardioverter defibrillators may fail to deliver therapy due to a rare feedthrough defect affecting 727 units 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 requires minimum severity 4. Although no illnesses or deaths have been reported and the hazard is rare and potential, the device is life-critical and directly impacts cardiac function delivery.
Plain-English summary
Medtronic Inc. is recalling 727 units of the EVERA XT implantable cardioverter defibrillators (ICDs) with model number DDBB2D4. The devices contain a specific defective feedthrough component that could lead to reduced or no energy output during high voltage therapy delivery.
The recall involves ICDs manufactured with a glassed feedthrough defect. This defect creates a rare potential for the device to fail in delivering critical high voltage therapy (typically 0-12J) for heart rhythm management.
The affected devices have been distributed nationwide and worldwide. Patients with affected devices should contact Medtronic or their healthcare provider immediately. Healthcare providers can reference the specific lot serial numbers and product codes provided in the FDA recall notice to determine if they have affected devices.
The recalled product
- Product
- ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; 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 00643169217928
- Lot Serial Numbers: BWD609356S
- BWD609450S
- BWD609318S
- BWD609387S
- BWD609454S
- BWD609558S
- BWD609464S
- BWD609549S
- BWD609355S
- BWD609467S
- BWD609389S
- BWD609343S
- BWD609397S
- BWD609567S
- BWD609395S
- BWD609462S
- BWD609470S
- BWD609316S
- BWD609554S
Distribution
Distributed nationwide across the United States.
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