Medtronic ICD defibrillators may fail to deliver critical therapy
Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.
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 mandates a minimum severity score of 4 per the rubric. The recalled devices are life-critical implants designed to deliver emergency electrical therapy for dangerous heart rhythms. Although the source does not report any confirmed illnesses or deaths, the potential for therapy failure during a life-threatening arrhythmia represents serious health risk.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that were manufactured with a specific glassed feedthrough component. These devices carry a rare potential for reduced or absent energy output during high-voltage therapy delivery.
ICDs and CRT-Ds are designed to monitor heart rhythm and deliver electrical therapy to correct life-threatening arrhythmias. A failure to deliver energy during therapy could prevent treatment of critical arrhythmias when the patient needs it most. The affected devices were distributed nationwide and worldwide.
The FDA classified this as a Class I recall due to the critical nature of these devices and their role in life-saving treatment. Patients with affected devices should contact their cardiologist or the manufacturer to determine if their device is included in the recall and to discuss appropriate next steps, which may include device monitoring or replacement.
The recalled product
- Product
- ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- no-energy-output
- 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 (14)
- GTIN 00643169720763
- Lot Serial Numbers: BWT600023S
- BWT600013S
- BWT600014S
- BWT600025S
- BWT600029S
- BWT600030S
- BWT600032S
- BWT600033S
- BWT600034S
- BWT600024S
- GTIN 00763000052706
- Lot Serial Numbers: BWT600040S
- BWT600038S
Distribution
Distributed nationwide across the United States.
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