Implantable cardioverter defibrillators (ICD) with cardiac resynchronizati ...



Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Components:
Recall Date:    Feb 3, 2021
Mfg:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Mfg Country:
United States
Recall ID:    87261
Product ID:    185642
Enforcement Date:    Apr 7, 2021
Last Published:    Mar 27, 2021

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Emert Number:    Z-1306-2021
Emert Status:    Announced