Recall Z-1496-2022— 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 2022-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Merlin 2 PCS MER37000 programmer Model MER3400 software. Reason: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up..
- Recalling firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-17
- Firm location
- Sylmar, CA, United States
Product description
Merlin 2 PCS MER37000 programmer Model MER3400 software
Reason for recall
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Data sourced from openFDA. This site is unofficial and independent of the FDA.