Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 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 of implantable cardioverter defibrillators, a life-critical medical device. Per the rubric, FDA Class I recalls cannot be scored below 4, regardless of reported illnesses or injuries. The hazard—potential failure of high voltage therapy output—represents a functional defect in a device essential for cardiac rhythm management.
Plain-English summary
Medtronic Inc. has recalled the ICD-VR DVFB1D1 VISIA AF MRI US DF1 implantable cardioverter defibrillator (ICD). The recall affects 12,099 units distributed nationwide and worldwide.
The recall addresses a rare potential for reduced or absent energy output during high voltage (HV) therapy, typically at 0-12 joules. This defect affects implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component.
Patients with implanted devices from the affected lot numbers are identified by specific serial numbers listed in the recall documentation. The affected lot numbers can be verified through implant records or by contacting Medtronic.
Patients should consult their healthcare provider or cardiologist regarding their specific device. The FDA and Medtronic recommend that physicians assess whether their patients with affected devices require any clinical intervention.
The recalled product
- Product
- ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- therapy-failure
- energy-output-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 00643169837799
- Lot Serial Numbers: CWG208686H
- CWG211264H
- CWG205930H
- CWG208117H
- CWG210956H
- CWG210958H
- CWG211814H
- CWG212178H
- CWG208135H
- CWG209489H
- CWG209599H
- CWG212702H
- CWG214349H
- CWG214379H
- CWG206584H
- CWG208347H
- CWG206776H
- CWG206895H
- CWG211478H
Distribution
Distributed nationwide across the United States.
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