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
- Affected units
- 522
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.
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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