Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF…

Recall date

December 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0582-2018

FDA classification

Class I

Brand / firm

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

Sold / distributed

US Nationwide Distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) 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).