Implantable Defibrillators Risk Reduced or No Energy Output During Therapy
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.
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 severity rubric requires a minimum score of 4. Since no illnesses or injuries have been reported, the score is 4 (Severe) rather than 5 (Critical).
Plain-English summary
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DDBB2D1 (EVERA XT IS1/DF1 INTL). The recall involves 2,282 units manufactured with a specific glassed feedthrough.
The recalled devices carry a rare potential for reduced or no energy output during high voltage (HV) therapy, typically 0-12 joules. This could affect the device's ability to deliver treatment.
The affected devices are distributed nationwide and worldwide. Patients with implanted devices from this recall should contact their physician or healthcare provider to determine if their device is affected and discuss appropriate next steps.
The recalled product
- Product
- ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-failure
- 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 00643169217911
- Lot Serial Numbers: BWE613480S
- BWE613110S
- BWE613432S
- BWE613202S
- BWE613100S
- BWE613096S
- BWE613185S
- BWE613258S
- BWE613431S
- BWE612802S
- BWE612865S
- BWE613214S
- BWE613235S
- BWE612884S
- BWE612956S
- BWE613098S
- BWE613122S
- BWE613143S
- BWE613171S
Distribution
Distributed nationwide across the United States.
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