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St. Jude Medical, Cardiac Rhythm Management Division Recalls
14 recalls on record · September 10, 2014 to August 10, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 10, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin.net model MN5000 Software
Hazard: 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.
August 10, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER37000 programmer Model MER3400 software
Hazard: 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.
August 10, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software
Hazard: 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.
April 27, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Hazard: 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 inability to remotely monitor these devices and resulted in reduced battery longevity.
April 27, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Hazard: 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 inability to remotely monitor these devices and resulted in reduced battery longevity.
April 27, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Hazard: 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 inability to remotely monitor these devices and resulted in reduced battery longevity.
April 27, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER3700 programmer Model MER3400 software
Hazard: 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.
April 27, 2022Medical DevicesFDA
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software
Hazard: 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.
March 4, 2020Medical DevicesFDA
St Jude Medical, Cardiac Rhythm Management Division recalls Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (0541473450
Hazard: Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
January 22, 2020Medical DevicesFDA
St Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile.
Hazard: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
January 27, 2016Medical DevicesFDA
St Jude Medical Cardiac Rhythm Management Division recalls Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical.
Hazard: Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
September 23, 2015Medical DevicesFDA
St Jude Medical Cardiac Rhythm Management Division recalls Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable p
Hazard: Some devices exhibit backup VVI operation due to a backup reset.
January 21, 2015Medical DevicesFDA
St Jude Medical Cardiac Rhythm Management Division recalls Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Trans
Hazard: Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
September 10, 2014Medical DevicesFDA
St Jude Medical Cardiac Rhythm Management Division recalls Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ell
Hazard: An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.