Recall Z-1495-2022— 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 PCS 3650 programmer Model 3330 software. Reason: There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers..
- 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 PCS 3650 programmer Model 3330 software
Reason for recall
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.