Recall Z-0587-2018— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class I FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2017-12-19, terminated 2021-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) 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: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)..

Recalling firm

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

Classification

Class I

Status

Terminated

Initiated

2017-12-19

Terminated

2021-08-27

Firm location

Mounds View, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.