Recall Z-2784-2015— St Jude Medical Cardiac Rhythm Management Division
Class II · Terminated
Class II FDA medical device recall by St Jude Medical Cardiac Rhythm Management Division, initiated 2015-08-18, terminated 2016-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.. Reason: Some devices exhibit backup VVI operation due to a backup reset..
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-18
- Terminated
- 2016-05-19
- Firm location
- Sylmar, CA, United States
Product description
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Reason for recall
Some devices exhibit backup VVI operation due to a backup reset.
Data sourced from openFDA. This site is unofficial and independent of the FDA.