PlainRecalls
FDA Devices Critical Class I Terminated

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4)

Reported: February 28, 2018 Initiated: December 19, 2017 #Z-0584-2018

Product Description

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

Reason for Recall

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

Details

Units Affected
951 devices total
Distribution
US Nationwide Distribution.
Location
Mounds View, MN

Frequently Asked Questions

What product was recalled? ▼
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 951 devices total.
Why was this product recalled? ▼
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Critical. Recall number: Z-0584-2018.

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