Recall – Implantable cardioverter programmer incorrectly functions

Company: St. Jude Medical, Cardiac Rhythm Management Division
Date of Enforcement Report: 4/27/2022
Class II

PRODUCT

REASON

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

RECALLING FIRM/MANUFACTURER

St. Jude Medical, Cardiac Rhythm Management Division on 4/27/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

30,069 devices with software

DISTRIBUTION

U.S. Nationwide and International