Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Certain Medtronic ICDs manufactured with a specific feedthrough may fail to deliver high-voltage therapy. Patients should contact their healthcare provider immediately.
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 score of 4. No illnesses or injuries have been reported. The hazard involves potential failure of a critical cardiac therapy function.
Plain-English summary
Medtronic is recalling certain Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) models manufactured with a specific glassed feedthrough. The EVERA S IS1/DF1 model (DDBC3D1) is the subject of this recall, affecting approximately 5,176 units distributed nationwide and internationally.
These devices carry a rare potential for reduced or completely absent energy output during high-voltage (HV) therapy, typically at 0-12 joules. If this malfunction occurs, the device may fail to deliver necessary therapy when needed to restore a normal heart rhythm during a cardiac emergency.
Patients with affected devices should contact their healthcare provider or Medtronic immediately to discuss evaluation options and potential device management. Healthcare providers have been notified of this recall and specific lot serial numbers have been identified. Patients should check their device documentation to determine if their device is included in this recall.
The recalled product
- Product
- ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- energy-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 00643169720411
- Lot Serial Numbers: BWG208720H
- BWG208284H
- BWG208405H
- BWG208608H
- BWG208700H
- BWG208763H
- BWG208301H
- BWG208376H
- BWG208406H
- BWG208412H
- BWG208520H
- BWG208539H
- BWG208652H
- BWG208716H
- BWG208296H
- BWG208340H
- BWG208484H
- BWG208220H
- BWG208234H
Distribution
Distributed nationwide across the United States.
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