St. Jude Medical, Cardiac Rhythm Management Division Recalls

All product recalls associated with St. Jude Medical, Cardiac Rhythm Management Division.

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Recall Summary

Total Recalls

11

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–11 of 11 recalls

St. Jude Medical, Cardiac Rhythm Management Division: 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.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: 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.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin.net model MN5000 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.

FDAJun 17, 2022AL, AK, AZ +49 more• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin PCS 3650 programmer Model 3330 software

Laceration Risk

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.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER3700 programmer Model MER3400 software

Laceration Risk

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.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant VR Implantable Cardioverter Defibrillator REF # C...

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.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant DR Implantable Cardioverter Defibrillator REF # C...

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.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division: Gallant HF Implantable Cardioverter Defibrillator REF# CD...

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.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

St Jude Medical, Cardiac Rhythm Management Division: Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (...

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.

FDAJan 22, 2020AZ, CA, DE +16 more• St Jude Medical, Cardiac Rhythm Management Division

St Jude Medical Cardiac Rhythm Management Division: Merlin@home RF Remote Monitoring Transmitter, Model EX115...

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.

Class IIModerate

FDADec 18, 2014Nationwide• St Jude Medical Cardiac Rhythm Management Division

St Jude Medical Cardiac Rhythm Management Division: Ellipse Implantable Cardioverter Defibrillators (ICDs), ...

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.

Class IIModerate

FDAAug 19, 2014Nationwide• St Jude Medical Cardiac Rhythm Management Division

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St. Jude Medical, Cardiac Rhythm Management Division Recalls

Recall Summary

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER37000 programmer Model MER3400 software

St. Jude Medical, Cardiac Rhythm Management Division: Merlin PCS 3650 programmer Model 3330 software

St. Jude Medical, Cardiac Rhythm Management Division: Merlin.net model MN5000 Software

St. Jude Medical, Cardiac Rhythm Management Division: Merlin PCS 3650 programmer Model 3330 software

St. Jude Medical, Cardiac Rhythm Management Division: Merlin 2 PCS MER3700 programmer Model MER3400 software

St. Jude Medical, Cardiac Rhythm Management Division: Gallant VR Implantable Cardioverter Defibrillator REF # C...

St. Jude Medical, Cardiac Rhythm Management Division: Gallant DR Implantable Cardioverter Defibrillator REF # C...

St. Jude Medical, Cardiac Rhythm Management Division: Gallant HF Implantable Cardioverter Defibrillator REF# CD...

St Jude Medical, Cardiac Rhythm Management Division: Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (...

St Jude Medical Cardiac Rhythm Management Division: Merlin@home RF Remote Monitoring Transmitter, Model EX115...

St Jude Medical Cardiac Rhythm Management Division: Ellipse Implantable Cardioverter Defibrillators (ICDs), ...