Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
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: This is an FDA Class I recall, which per the rubric requires a minimum severity score of 4 (Severe). The defect affects critical therapy delivery in life-saving cardiac devices. Although no illnesses or deaths have been reported, the potential for device failure during therapy represents serious risk.
Plain-English summary
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDBB1D4 (EVERA XT IS1/DF4 US). A total of 522 units manufactured with a specific feedthrough component have been identified in this recall.
The defect presents a rare potential for reduced or no energy output during high-voltage therapy (typically 0-12 joules). This issue stems from the specific feedthrough component used in the affected devices. The FDA has classified this as a Class I recall.
The affected devices have been distributed nationwide in the United States and worldwide. Multiple lot serial numbers are associated with the recalled units.
The recalled product
- Product
- ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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 00643169720374
- Lot Serial Numbers: BWB231977H
- BWB232204H
- BWB231981H
- BWB231888H
- BWB232232H
- BWB232076H
- BWB231876H
- BWB231908H
- BWB231979H
- BWB232244H
- BWB232310H
- BWB231918H
- BWB232114H
- BWB231867H
- BWB232361H
- BWB231879H
- BWB231847H
- BWB232311H
- BWB232048H
Distribution
Distributed nationwide across the United States.
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