St. Jude Medical, Cardiac Rhythm Management Division recalls
4 official recalls and safety alerts involving St. Jude Medical, Cardiac Rhythm Management Division since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with St. Jude Medical, Cardiac Rhythm Management Division or the relevant agency.
- 2022-08-10
USSt. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER37000 programmer Model MER3400 software
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.
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software
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.
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice → - 2022-04-27
- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the…
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - US Nationwide distribution in the states of FL, KY…Official notice → - US
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER3700 programmer Model MER3400 software
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,…
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →