Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR

Is my product affected?

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, ventricular tachycardia, fast ven

• UPC 00643169566347
• UPC 00643169566354
• UPC 00643169929760

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 951 Visia AF Implantable Cardioverter Defibrillators (ICDs) and related cardiac devices distributed nationwide in the United States. These devices may fail to deliver high and low voltage therapy, which are critical functions designed to treat dangerous heart rhythms. The affected devices include Visia AF VR ICD models with specific serial numbers beginning with "BWN" or "BWP" prefixes.

The recall notice does not specify what consumers or patients should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Details from the source

Reason for recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). Distribution: US Nationwide Distribution. Quantity: 951 devices total Lot/code info: a. Product No. DVAB1D1: UDI 00643169566347 (Serial No. BWN201126H) (EXPANSION: Serial No. BWN202016H, BWN202327H, BWN202334H, BWN202335H); EXPANSION: b. Product No. DVAB1D4: UDI 00643169566354 (Serial No. BWP201614H, BWP201658H, BWP201660H, BWP201669H, BWP201782H, BWP201783H), 00643169929760 (Serial No. BWP201661H)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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