Recall Z-0964-2022— St. Jude Medical, Cardiac Rhythm Management Division
Class II · Ongoing
Class II FDA medical device recall by St. Jude Medical, Cardiac Rhythm Management Division, initiated 2022-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Merlin PCS 3650 programmer Model 3330 software. 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
- St. Jude Medical, Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-10
- Firm location
- Sylmar, CA, United States
Product description
Merlin PCS 3650 programmer Model 3330 software
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.