Implantable defibrillators may fail to deliver high-voltage therapy due to defect
Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.
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 a FDA Class I recall of implantable cardiac devices with potential for complete therapy failure. While no deaths, serious injuries, or hospitalizations are reported in the source, the hazard is critical for a life-saving device. Class I classification mandates a minimum severity level of Severe, with Critical reserved for recalls with reported deaths or serious injuries.
Plain-English summary
Medtronic Inc. has recalled 2,179 units of the EVERA XT IS1/DF1 defibrillators (ICDs and CRT-Ds) distributed nationwide and worldwide. The recall concerns a rare potential for reduced or complete loss of energy output during high-voltage therapy, typically at 0-12J, in devices manufactured with a specific glassed feedthrough.
Affected devices are identified by GTIN 00643169720404 and GTIN 00763000059569 with specific lot numbers beginning with BWC. The defect affects both standard implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Patients who have received one of these devices should contact their cardiologist or healthcare provider to determine if their device is affected and discuss appropriate monitoring or replacement options. The FDA classified this as a Class I recall.
The recalled product
- Product
- ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- electrical-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 00643169720404
- Lot Serial Numbers: BWC242988H
- BWC241999H
- BWC242338H
- BWC242392H
- BWC243112H
- BWC243417H
- BWC243633H
- BWC243786H
- BWC244004H
- BWC241880H
- BWC242816H
- BWC243834H
- BWC241861H
- BWC242999H
- BWC241742H
- BWC241891H
- BWC241930H
- BWC242022H
- BWC242027H
Distribution
Distributed nationwide across the United States.
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