FDA recall Z-1528-2021

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

CareLink SmartSync Device Manager - 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, Model Number 24970A

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2021-04-06
Report date: 2021-05-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1528-2021