Recall Z-1305-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class I FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.. Reason: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation.

Recalling firm

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

Classification

Class I

Status

Ongoing

Initiated

2021-02-03

Firm location

Mounds View, MN, United States

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