Home / Recalls / Medical Devices
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also prov
Recalled May 12, 2021 · FDA recall Z-1527-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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. · FDA Class II
Units
37690 units
Sold at
Worldwide distribution.
Description
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.
Product
Programmers - 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. 2090 Carelink 2. 29901 Encore
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →