Agency classClass IOur severity:Severe FDA (Devices)·Z-0589-2018·Announced 2018-02-28

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.

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: 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…
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: therapy-failure
device-malfunction
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 →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

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Same hazard · therapy failure