Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 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 recall meets the criteria for FDA Class I classification, the highest regulatory concern level. The defect affects critical life-support devices designed to prevent sudden cardiac death. Although no illnesses or deaths are reported in the source, the potential for therapy failure due to reduced energy output during high-voltage therapy could result in serious cardiac harm.
Plain-English summary
Medtronic Inc. has recalled the ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1 model implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These devices were manufactured with a specific glassed feedthrough component. Approximately 4,546 units are affected by this recall, distributed nationwide and worldwide.
The devices have a rare potential to produce reduced or no energy output during high-voltage therapy, typically delivered at 0-12 joules. This defect is associated with the specific feedthrough design. Reduced energy output could prevent the device from delivering therapy when needed, potentially affecting its ability to correct life-threatening heart rhythms.
Patients with implanted affected devices should contact their healthcare provider to determine whether their specific device is included in the recall and to receive guidance on appropriate next steps. The affected models are currently in use and remain functional for essential heart rhythm protection.
The recalled product
- Product
- ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- 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 00643169837805
- Lot Serial Numbers: CWH604762S
- CWH602704S
- CWH604287S
- CWH601113S
- CWH602355S
- CWH601417S
- CWH601422S
- CWH601423S
- CWH603581S
- CWH602459S
- CWH602700S
- CWH601632S
- CWH601887S
- CWH602686S
- CWH602952S
- CWH603048S
- CWH604506S
- CWH604849S
- CWH605365S
Distribution
Distributed nationwide across the United States.
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