Company: St. Jude Medical, Cardiac Rhythm Management Division
Date of Enforcement Report: 4/27/2022
Class II
PRODUCT
Merlin PCS 3650 programmer Model 3330 software
Recall Number:
Z-0964-2022
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