ST Jude Medical Cardiac Rhythm Management Division

Reports per year

Source: FDA adverse event reports by year received, 2000–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Permanent Pacemaker ElectrodeDTB12,982
• Permanent Defibrillator ElectrodesNVY12,133
• Implantable Cardioverter Defibrillator (Non-Crt)LWS9,097
• Implantable Pacemaker Pulse-GeneratorDXY8,530
• Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN5,760
• Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3,800
• Implantable Pulse Generator, Pacemaker (Non-Crt)LWP1,798
• Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX679
• Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC197
• Catheter, PercutaneousDQY70

Recent recalls

• 2016-01-21TerminatedProcess control

  Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).

  Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.

• 2015-09-28TerminatedSoftware change control

  Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

  Some devices exhibit backup VVI operation due to a backup reset.

• 2015-01-09TerminatedDevice Design

  Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

  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.

• 2014-09-03TerminatedComponent design/selection

  Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

  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.

• TerminatedProcess control

  Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

  Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.

• Open, ClassifiedSoftware design

  Merlin PCS 3650 programmer Model 3330 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, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

• Open, ClassifiedSoftware design

  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, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

• Open, ClassifiedComponent design/selection

  Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

  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.

• Open, ClassifiedComponent design/selection

  Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

  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.

• Open, ClassifiedComponent design/selection

  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 inability to remotely monitor these devices and resulted in reduced battery longevity.