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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 2,282
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.
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
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
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- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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Same hazard · energy output failure
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
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- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators risk energy output failure during high voltage therapy
FDA (Devices) · 2023-06-28
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