Recall Z-1526-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.. Reason: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted..

Recalling firm

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

Classification

Class II

Status

Ongoing

Initiated

2021-04-06

Firm location

Mounds View, MN, United States

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