MOMENTUM™ EL ICD VR D120Recalls & reported problems

Summary

The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 00802526587702), received between Jan 25, 2018 and Sep 29, 2026 — classified as 2 deaths, 153 injuries, 160 malfunctions.

The most frequently reported specific device problem is “High impedance” (139 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); 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 315 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High impedance; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935760 ↗
• InjurySep 25, 2026Premature Discharge of Battery; Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system recorded a code 1004 indicative of a short circuit condition during shock delivery. Technical Services (TS) reviewed the data and noted there was a ventricular fibrillation (VF) episode. A shock was delivered and converted the rhythm; however, it resulted in a short. TS analysis also concluded the device did not record a code 1004, but the shock resulted in a low out of range shock impedance measurement. It was also noted this ICD system recorded a code 1003, which states that the voltage is too low for projected remaining capacity. The code 1003 was recorded due to the low shocking lead impedance. TS recommended replacing the entire ICD system. It was noted the patient would see the physician to discuss possible system extraction. Additionally, the patient is currently wearing a life vest until future plans are solidified and that tachy therapy was turned off. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899894 ↗
• InjurySep 24, 2026Defibrillation/Stimulation Problem; Unexpected Therapeutic Results

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) recorded ventricular episodes with therapy. At one of the episodes anti-tachycardia pacing (ATP) accelerated the rhythm to the ventricular fibrillation zone and was successfully converted by an electric shock. The ICD remains in service at this time. No additional adverse patient effects were reported.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50889970 ↗
• MalfunctionSep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50829627 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) was hospitalized into the intensive care unit. It was mentioned that the patient required chest compressions. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50810121 ↗
• MalfunctionSep 17, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements of 160 ohms. Technical Services (TS) was consulted and lead revision procedure if measurements rise above 150 ohms was recommended. No adverse patient effects were reported. This device remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805857 ↗
• MalfunctionSep 14, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50765182 ↗
• MalfunctionSep 9, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range pace impedance measurements which subsequently dropped. Technical Services (TS) was consulted and found a non-Boston Scientific right ventricular lead was implanted which had an old header. TS noted the caller denied non-physiological noise and recommended troubleshooting with isometrics and pocket manipulation. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690577 ↗
• InjurySep 7, 2026High impedance; Failure to Convert Rhythm; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651005 ↗
• InjurySep 4, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range pacing impedances above 3000 Ohms on the right ventricular (RV) channel. It was noted that the associated RV lead is a non-Boston Scientific product, which was surgically abandoned. This ICD was explanted and successfully replaced with a cardiac resynchronization therapy defibrillator (CRT-D) device. No additional adverse patient effects were reported. This ICD was retained by the healthcare facility and therefore is not expected to be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613471 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602207 ↗
• InjuryAug 21, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50376478 ↗
• InjuryAug 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate anti-tachycardia pacing (ATP) during a sinus tachycardia episode. Upon further review of the episode, Boston Scientific Technical Services (TS) discussed the RHYTHMMATCH was not appropriately correlated due to the misalignment of the template with the shock EGM. Reprogramming options were discussed. No adverse patient effects were reported. This device remains in service.The complaint device was not returned to Boston Scientific, therefore, product analysis could not be performed.Additional information was received that this device was suspected of delivering inappropriate ATP and electric shocks. Further evaluation by cardiology was recommended. No additional adverse patient effects were reported. This device remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50150248 ↗
• MalfunctionJul 31, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104212 ↗
• InjuryJul 29, 2026High impedance; Failure to Convert Rhythm; Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited a product performance issue. The patient underwent a surgical intervention to remove the ICD and implant a new product. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073435 ↗
• InjuryJul 27, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered one inappropriate shock therapy and anti-tachycardia pacing (ATP) due to possible rapid ventricular response (RVR). This device remains in service. No adverse patient effects were reported.Additional information was received which indicated that, this ICD delivered another inappropriate shock and anti-tachycardia pacing (ATP) due to possible rapid ventricular response (RVR) due to atrial arrhythmia. Therapy did not convert rhythm. There were not out of range measurements. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50012564 ↗
• MalfunctionJul 21, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range pace impedance measurements. Technical Services (TS) was consulted and reviewed historical measurements, noting they previously remained stable. TS reviewed the presenting electrogram and saw no noise and no stored events with the exception of threshold testing. TS suggested an in clinic evaluation of isometrics and pocket manipulation to check for noise. If no noise was produced and measurements were within normal limits, TS recommended to continue monitoring. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892892 ↗
• InjuryJul 17, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND MULTIPLE SHOCKS FOR APPARENT EPISODES OF SUPRAVENTRICULAR TACHYCARDIA (SVT). THERAPY WAS EXHAUSTED. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER REVIEW WITH THE CLINIC, AND VT-1 ZONE WAS CHANGED ALONG WITH DURATION. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25856120 ↗
• MalfunctionJul 13, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED FLUCTUATING HIGH OUT OF RANGE (OOR) SHOCK IMPEDANCE MEASUREMENTS ABOVE 125 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED POSSIBLE REASONS FOR THE EXHIBITED BEHAVIOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808456 ↗
• InjuryJul 8, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND TWO SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). IT WAS NOTED THAT THIS WAS A SINGLE CHAMBER SYSTEM, MAKING DETERMINATION OF THE RHYTHM ORIGIN MORE CHALLENGING. IT WAS FURTHER NOTED THAT THE INITIAL THERAPY DID NOT TERMINATE THE RHYTHM; HOWEVER, THE SECOND SHOCK SUCCESSFULLY TERMINATED THE EPISODE. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25757019 ↗
• MalfunctionJul 7, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING OF NOISE. IT WAS NOTED THERE WAS NO PACING INHIBITION. TECHNICAL SERVICES (TS) DETERMINED THE NOISE APPEARED TO LOOK LIKE CAUTERY. THE HEALTH CARE PROFESSIONAL (HCP) CONFIRMED THE PATIENT WAS HAVING EYE SURGERY THAT DAY. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740476 ↗
• InjuryJul 1, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS FOR AN APPARENT ATRIAL DRIVEN ARRYTHMIA. THERAPY WAS EXHAUSTED. THE DEVICE REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 25685741 ↗
• MalfunctionJun 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK DURING AN EPISODE OF ATRIAL DRIVEN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 25673590 ↗
• MalfunctionJun 30, 2026Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT T WAVE OVERSENSING ON THE PRESENTING ELECTROGRAM (EGM). TECHNICAL SERVICES (TS) ATTEMPTED TO MITIGATE THE ISSUE BY EXTENDING THE VENTRICULAR REFRACTORY PERIOD AND ADJUSTING SENSITIVITY; HOWEVER, THESE CHANGES COULD NOT BE IMPLEMENTED. AS THE DEVICE WAS BEING PROGRAMMED TO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE IMPEDANCE MEASUREMENTS WERE PERFORMED AND MOST RECENT MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM MRI PROTECTION MODE WITHOUT ISSUE, AND IMPEDANCE MEASUREMENTS REMAINED WITHIN THE EXPECTED RANGE. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673412 ↗
• MalfunctionJun 29, 2026Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED THE PRESENCE OF UNDERSENSING. IT WAS NOTED THAT THE CLINICIAN PLANNED TO BRING THE PATIENT INTO THE CLINIC FOR FURTHER EVALUATION. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650402 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · 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-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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551