Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
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 mandates a minimum severity score of 4. Although no illnesses or injuries are reported in the source text, the potential for therapy failure in life-sustaining implantable devices warrants severe classification.
Plain-English summary
Medtronic Inc. is recalling certain model DDBC3D4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a manufacturing defect. The affected devices may experience reduced or no energy output during high-voltage therapy delivery, typically in the 0 to 12-joule range.
The issue stems from a defect in the device's feedthrough component. In rare cases, this defect may result in insufficient energy delivery during critical therapy events, potentially compromising the device's life-saving function.
The recall affects approximately 4,056 units distributed nationwide and internationally. Patients with affected devices are identifiable by specific lot serial numbers listed in the FDA recall notice.
Patients with affected ICDs or CRT-Ds should contact their healthcare provider or Medtronic to determine if their device is affected. Patients should maintain regular monitoring and follow-up appointments with their cardiologist.
The recalled product
- Product
- ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
- Affected units
- 4,056
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 00643169720381
- Lot Serial Numbers: BWF206541H
- BWF206448H
- BWF206403H
- BWF206382H
- BWF206552H
- BWF206320H
- BWF206323H
- BWF206420H
- BWF206376H
- BWF206458H
- BWF206459H
- BWF206430H
- BWF206453H
- BWF206359H
- BWF206478H
- BWF206333H
- BWF206365H
- BWF206370H
- BWF206557H
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
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