MOMENTUM™ CRT-D G125Recalls & reported problems

Summary

The FDA's MAUDE database contains 792 adverse event reports that list this exact device (DI 00802526589126), received between Oct 29, 2018 and Sep 28, 2026 — classified as 4 deaths, 387 injuries, 401 malfunctions.

The most frequently reported specific device problem is “High impedance” (205 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 792 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Loss of consciousness; Pain; Syncope/Fainting

  MAUDE report 50926592 ↗
• InjurySep 24, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and the right ventricular (RV) lead delivered an inappropriate shock due to oversensing of noise. Also, there was a high out of range shock impedance, greater than 200 Ohms. It was noted that during the defibrillation threshold (DFT) test at device implant, there was a high out of range shock impedance, greater than 200 Ohms. The field representative resolved the noise on the RV lead by reprogramming the device. This CRT-D and this RV lead were subsequently explanted due to these observations. This CRT-D was replaced. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50884379 ↗
• MalfunctionSep 23, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited oversensed noise and pacing inhibition. The patient experienced dizziness. Technical Services (TS) was contacted and noted that the noise appeared to be electromagnetic interference (EMI). TS also recommended follow up. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Asystole

  MAUDE report 50869893 ↗
• InjurySep 17, 2026Failure to Capture; Insufficient Device Problem Information; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812530 ↗
• MalfunctionSep 17, 2026Failure to Capture; High impedance; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and left ventricular (LV) lead exhibited pacing impedance measurements that were high and out of range, as well as loss of capture (LOC). It was noted that evaluation of the LV lead for possible replacement was planned. The patient was programmed to right ventricular (RV) only pacing. This CRT-D and LV lead remain in service. No adverse patient effects were reported.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 50798181 ↗
• MalfunctionSep 8, 2026Failure to Capture; Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678900 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: Asystole

  MAUDE report 50612127 ↗
• InjurySep 4, 2026Failure to Capture; Over-Sensing; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system was scheduled for battery replacement. During the procedure, the non Boston Scientific left ventricular (LV) lead showed no capture in LV only at 7.5 V, however LV capture in was observed in temp brady while in VOO mode. It was determined that LV sensing was programmed off due to right atrial (RA) oversensing, and the LV EGM appeared flat during LV threshold testing and temp brady. The only difference was that RVS was allowed during the threshold test, which reset the timing. During the battery replacement procedure, three distinct morphologies were observed. Further testing was performed in right ventricular (RV) only pacing, which had similar capture to the LV. None of the LV ring configurations had capture and the cause was not identified. CRT-D explant was completed successfully. No additional adverse patient effects were reported. Product return was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603670 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50600228 ↗
• MalfunctionSep 1, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551889 ↗
• MalfunctionAug 30, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510330 ↗
• MalfunctionAug 24, 2026Failure to Capture; High impedance; Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408005 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There was no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50208506 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50207590 ↗
• DeathAug 6, 2026Over-Sensing; Pacing Problem; Defibrillation/Stimulation Problem

  It was reported that the patient had an ablation procedure for ventricular tachycardia (VT) on (b)(6) 2026. Subsequent to the ablation, on (b)(6) the patient was going in and out of slow VT; the cardiac resynchronization therapy defibrillator (CRT-D) was set to 100 beats/minute in an effort to pace through the VT. Burst pacing was tried and the patient's arrhythmia accelerated, requiring a shock, which successfully converted. A Lidocaine drip and propranolol were also administered. It was planned at the time to examine further medical management for the patient. The VT returned and it was observed that the left ventricular lead (LV) was inhibiting pacing. Technical Services discussed that it was likely health-related. It was further reported that this patient passed away on (b)(6) 2026. The patient was to be cremated, and it was not stated whether the device system would be returned. Additional information is being requested.

  Patient problems: Tachycardia

  MAUDE report 50165504 ↗
• InjuryJul 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) received anti-tachycardia pacing (ATP) and multiple shocks for supraventricular tachycardia (SVT) episodes. Therapy was exhausted. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50070998 ↗
• InjuryJul 27, 2026Unexpected Therapeutic Results

  It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (CRT-D) system presented to the emergency room (ER), and review of the presenting electrogram (EGM) showed possible left-sided ventricular tachycardia (VT). A full device interrogation was planned for later that day. Additional information received reported that the patient was found to be in slow VT below the programmed detection rate, and the patient was was externally cardioverted to normal sinus rhythm successfully. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047326 ↗
• MalfunctionJul 27, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50026901 ↗
• MalfunctionJul 21, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894098 ↗
• MalfunctionJul 16, 2026Failure to Capture; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXPERIENCED A SYNCOPAL EPISODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED EVIDENCE OF UNDERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL, ALONG WITH LOW INTRINSIC AMPLITUDES. ADDITIONALLY, INTERMITTENT LOSS OF CAPTURE (LOC) WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THE HEALTHCARE PROFESSIONAL (HCP) REQUESTED THAT A LOCAL COMPANY REPRESENTATIVE BE PAGED FOR AN IN PERSON EVALUATION. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25847638 ↗
• InjuryJul 15, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A MYOCARDIAL INFARCTION. THIS CRT-D PROVIDED EIGHT SHOCKS THAT DIDN'T CONVERT THE RHYTHM. EMERGENCY MEDICAL SERVICES (EMS) PERFORMED CARDIOPULMONARY RESUSCITATION (CPR) AND DELIVERED AN EXTERNAL SHOCK TO THE PATIENT. THE FIELD REPRESENTATIVE (REP) INTERROGATED THE DEVICE AND OBSERVED AN OPEN CIRCUIT ALERT. ALSO, THE RV LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE, THAT WAS SUSPECTED TO BE GREATER THAN 145 OHMS. THE SHOCK WAS MONOPHASIC AND ENERGY WAS TRUNCATED. THE PATIENT WAS TRANSFERRED TO A LEVEL ONE TRAUMA CENTER FOR A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AND POSSIBLE TRANSPLANT. TS DISCUSSED THAT THE PATIENT NEEDED A NEW RV LEAD SINCE THE LEAD COULDN'T DEFIBRILLATE THE PATIENT. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830651 ↗
• MalfunctionJul 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) NOTED THEIR DEVICE WENT OFF WHEN IT WAS NOT SUPPOSED TO. THE PATIENT ALSO NOTED THEY WERE TOLD THEY HAD A DEFECTIVE DIODE AND IT WOULD BE FIXED WHEN THE DEVICE WAS CHANGED OUT. LIMITED INFORMATION WAS AVAILABLE. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THE DOCTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803433 ↗
• MalfunctionJul 9, 2026Interrogation Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was unable to be interrogated using a communicator. Technical Services (TS) was consulted and troubleshooting was performed but it was unsuccessful. This device remains in service. No adverse patient effects were reported.Additional information from the filed indicates this device was unable to be interrogated due errors on part of the user when attempting to interrogate the device. There were no device issues. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766995 ↗
• InjuryJul 8, 2026High impedance; Failure to Convert Rhythm; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXPERIENCED A VENTRICULAR FIBRILLATION EPISODE IN WHICH ALL PROGRAMMED SHOCKS WERE EXHAUSTED WITHOUT SUCCESSFUL CONVERSION. A SHOCK ON VENTRICULAR TACHYCARDIA (VT) INDUCED VENTRICULAR FIBRILLATION (VF). THE DEVICE RECORDED AN ALERT DUE TO SHOCK IMPEDANCE HIGH OUT OF RANGE. DURING REPEAT DEFIBRILLATION THRESHOLD TESTING, FOUR EPISODES OF INDUCED VENTRICULAR FIBRILLATION WERE NOT TERMINATED, REQUIRING EXTERNAL DEFIBRILLATION. THE PATIENT WAS REPORTED TO BE STABLE, AND NO SURGICAL INTERVENTION PLAN HAD BEEN DETERMINED AT THE TIME OF THE REPORT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 25757525 ↗
• InjuryJul 7, 2026Failure to Convert Rhythm; Under-Sensing

  It was reported that during a routine generator change, the physician reported a failed defibrillation threshold (DFT) test on this cardiac resynchronization therapy defibrillator (CRT-D) device. It was noted that at initial induction Automatic Gain Control (AGC) was at 0.6mV and there was undersensing. The patient required external shock to rescue. The device programming was optimized and procedure was completed successfully. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25741923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0825-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100

…and 4 more.