Medtronic Visia AF ICDs Recalled for Potential Therapy Failure
Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.
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: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or 5; given the lack of reported fatalities in the source text, a score of 4 is appropriate.
Plain-English summary
Medtronic Inc. is recalling 951 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) labeled as Visia AF VR ICD DF1 and Visia AF VR ICD DF4. These devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
The recall was initiated because the devices may fail to deliver high and low voltage therapy. This defect could prevent the device from providing necessary treatment for heart rhythm issues.
The affected devices were distributed nationwide in the United States. Patients with these specific devices should contact their healthcare provider for evaluation and potential replacement.
The recalled product
- Product
- Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation
- Affected units
- 951
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 (10)
- BWN202327H
- BWN202334H
- BWN202335H)
- EXPANSION: b. Product No. DVAB1D4: UDI 00643169566354 (Serial No. BWP201614H
- BWP201658H
- BWP201660H
- BWP201669H
- BWP201782H
- BWP201783H)
- 00643169929760 (Serial No. BWP201661H)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
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