MOMENTUM™ CRT-D G124Recalls & reported problems

Summary

The FDA's MAUDE database contains 790 adverse event reports that list this exact device (DI 00802526589102), received between Aug 7, 2018 and Sep 30, 2026 — classified as 5 deaths, 456 injuries, 329 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (146 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 790 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance; Failure to Read Input Signal; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system exhibited high pacing impedance measurements within range, high capture threshold, and low intrinsic amplitude. Technical Services (TS) recommended further review. This device remains in system. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949002 ↗
• InjurySep 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered inappropriate anti-tachycardia pacing (ATP) and inappropriate shocks due to supraventricular tachycardia (SVT). Technical Services (TS) reviewed and confirmed the device was atrial driven. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50946742 ↗
• MalfunctionSep 29, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933841 ↗
• MalfunctionSep 29, 2026Failure to Capture

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and non Boston Scientific left ventricular (LV) lead exhibited loss of capture (LOC). Technical Services (TS) was consulted and provided troubleshooting options. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927966 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917382 ↗
• MalfunctionSep 25, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system exhibited high out of range shock lead impedance measurements greater than 125 Ohms. Technical Services (TS) was consulted and upon data review discussed this is not a gradual rise. TS recommended programming enhancements and continue monitoring. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897179 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was explanted due to unknown reasons. Additional information was requested but unable to be obtained at this time. No additional adverse patient effects were reported. This CRT-D has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885489 ↗
• MalfunctionSep 24, 2026Over-Sensing; Pacing Problem

  It was reported that this device was oversensing signals from the right ventricular and left ventricular channel resulting in unexpected mode switches. Technical Services (TS) was consulted and recommended turning on ventricular rate regulation. TS noted an increase in biventricular pacing as a result of the unexpected mode switches. No adverse patient effects were reported. This device remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882217 ↗
• MalfunctionSep 23, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) stored inappropriate Atrial Tachy Response (ATR) episodes due to oversensed noise. Review of the available device data indicated that the episodes contained noise artifact on all leads and were most likely associated with electromagnetic interference (EMI) signals due to electrocautery use during the implant procedure. Technical Services (TS) reviewed the device data and determined that the device was operating as programmed. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869899 ↗
• MalfunctionSep 18, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) lead recorded high out of range shock impedance measurements on the right ventricular (RV) channel. Technical Services (TS) reviewed the available device data and identified a measurement of approximately 126 ohms. Further review indicated impedance variability over time and that there was no evidence of a gradual impedance rise. TS recommended a follow up device interrogation to confirm that the impedance did not continue to increase and consideration to increase the out of range alert threshold to 150 ohms. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820538 ↗
• InjurySep 16, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 50794740 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) had develop a pocket hematoma. This device was surgically revised and remains in service. No additional adverse patient effects were reported.

  Patient problems: Hematoma

  MAUDE report 50791211 ↗
• MalfunctionSep 16, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50790277 ↗
• InjurySep 16, 2026High impedance; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high shock impedance measurements that remained within normal limits. Additionally, the capture threshold on the right ventricular channel exhibited high measurements intermittently. The device was subsequently explanted, and a new device was successfully implanted. No additional adverse patient effects were reported. This CRT-D is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787470 ↗
• InjurySep 10, 2026Signal Artifact/Noise

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) was notified by their clinic of an alert associated with the implanted system. Technical Services (TS) was consulted; however, it could not be determined whether the alert was related to impedance measurements or signal amplitude measurements. The patient was subsequently evaluated in clinic, where noise was observed on the left ventricular (LV) channel. The local company representative performed troubleshooting to further assess the condition. Additionally, the patient reported that following the initial implant procedure, there had been fluid accumulation around the device and that the leads had perforated; however, no additional details regarding these reported events were available. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Swelling/ Edema

  MAUDE report 50705831 ↗
• InjurySep 9, 2026Failure to Convert Rhythm; Material Integrity Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) claimed their device was defective. Additionally, the patient reported that they received 6 shocks and were hospitalized. Technical Services (TS) was consulted and documented the patients concerns, further noting that the patient experienced pain from the delivered shocks and stated their incision was not healing. The patient additionally stated that they believe a Boston Scientific Technician detected an anomaly prior but was dismissed by a colleague. TS informed the patient why shocks occur. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Impaired Healing; Pain

  MAUDE report 50692772 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced dyspnea after their device settings were changed. Also, the patient experienced syncope and malaise. The patient presented to the emergency room (ER) but felt the ER didn't help them. Technical Services (TS) referred the patient to seek appropriate medical attention and to follow up with their clinic. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: Dyspnea; Malaise; Syncope/Fainting

  MAUDE report 50669324 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50642867 ↗
• InjurySep 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50600828 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50571398 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50571124 ↗
• InjurySep 2, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 50569232 ↗
• InjurySep 2, 2026Unexpected Therapeutic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566425 ↗
• InjuryAug 24, 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 50420752 ↗
• MalfunctionAug 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410392 ↗

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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• 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-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-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-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-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-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-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-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.