MOMENTUM™ CRT-D G126Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00802526589140), received between Jan 28, 2019 and Sep 23, 2026 — classified as 54 injuries, 61 malfunctions.

The most frequently reported specific device problem is “High impedance” (30 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 115 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869259 ↗
• InjurySep 18, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded a code 1003, which states that the voltage is too low for projected remaining capacity. A request was made to have data from this device analyzed. Data analysis confirmed that the battery is dropping in an irregular fashion. This could possibly be related to an internal electrical short of the battery. Device replacement was recommended. This device was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814292 ↗
• MalfunctionSep 16, 2026Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited farfield oversensing that led to an inappropriate mode switch. Technical Services (TS) reviewed and recommended changing the programming for this device. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783667 ↗
• MalfunctionSep 4, 2026Device Alarm System; Interrogation Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) emitted beep tones and patient initiated interrogation (PII) was unsuccessful. PII was disabled, and the Technical Services (TS) enabled one PII. The health care professional (HCP) will call the patient back to send the PII. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615710 ↗
• MalfunctionAug 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205078 ↗
• MalfunctionJul 1, 2026Device Alarm System; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT DURING AN IN OFFICE INTERROGATION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PHYSICIAN INFORMED THE PATIENT OF AN OBSERVATION THAT COULD POTENTIALLY RESULT IN SHOCK THERAPY DELIVERY. TECHNICAL SERVICES (TS) REQUESTED ADDITIONAL INFORMATION TO CLARIFY THE NATURE OF THE OBSERVATION; HOWEVER, THE PATIENT COULD NOT RECALL WHETHER THE OBSERVATION INVOLVED NOISE OVERSENSING WITHIN THE SYSTEM OR AN AUDIBLE DEVICE GENERATED ALERT. DUE TO THE POTENTIAL FOR NOISE OVERSENSING, TS RECOMMENDED THAT THE PATIENT SEEK FURTHER CLARIFICATION FROM THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686163 ↗
• InjuryJun 8, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CALLED TECHNICAL SERVICES (TS) AND REPORTED A SYNCOPAL EPISODE. A PATIENT INITIATED INTERROGATION (PII) WAS PERFORMED, HOWEVER THE TRANSMISSION INITIALLY FAILED. TS WALKED THE PATIENT THROUGH TROUBLESHOOTING EFFORTS. TROUBLESHOOTING EFFORTS WERE SUCCESSFUL. TS REFERRED THE PATIENT TO THE DEVICE TREATING CLINIC FOR FURTHER EVALUATION. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Syncope/Fainting

  MAUDE report 25437442 ↗
• MalfunctionMay 14, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LONGEVITY DECREASE OF APPROXIMATELY ONE YEAR WITHIN A THREE MONTH PERIOD, ACCORDING TO THE ADVOCATE FOR THIS PATIENT. TECHNICAL SERVICES (TS) WAS CONSULTED AND ADVISED THAT, FOR FURTHER INSIGHT AND DETAILED DISCUSSION, THE APPROPRIATE COURSE OF ACTION WAS FOR THE PATIENT TO CONTACT THEIR RESPECTIVE CLINIC, WHICH COULD ENGAGE WITH TS AS NEEDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174302 ↗
• MalfunctionMay 6, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED SHOCK LEAD IMPEDANCE HIGH OUT OF RANGE MEASUREMENTS GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW, RECOMMENDED PROGRAMMING ENHANCEMENTS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107175 ↗
• MalfunctionMar 26, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A SIGNAL ARTIFACT MONITOR (SAM) EPISODE DUE TO OVERSENSING ARTIFACT RELATED TO THE MINUTE VENTILATION (MV) FEATURE SIGNAL ON THE RIGHT ATRIAL (RA) LEAD. IN ADDITION, HIGH OUT OF RANGE PACING IMPEDANCES WERE OBSERVED ON THE SAM EPISODE. NO ADDITIONAL EPISODES OF NOISE WERE RECORDED. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700182 ↗
• InjuryMar 11, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS IDENTIFIED POTENTIAL HIGH IMPEDANCE WITHIN THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED AS THE BATTERY IMPEDANCE IS EXPECTED TO INCREASE, AND RADIO FREQUENCY (RF) TELEMETRY WILL EVENTUALLY BE DISABLED. THIS DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT THIS PACEMAKER WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570316 ↗
• MalfunctionFeb 27, 2026Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FARFIELD OVERSENSING IN THE RIGHT ATRIAL (RA) CHANNEL WHICH LED TO FALSE ATRIAL TACHY RESPONSE (ATR) EVENTS. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED POSSIBLE REPROGRAMMING OPTIONS. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474926 ↗
• MalfunctionFeb 26, 2026Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INTERMITTENT LEFT VENTRICULAR LOSS OF CAPTURE ON THE PRESENTING ELECTROGRAM. THE CLINICIAN PROVIDED THE PATIENT WOULD BE SEEN FOR FURTHER EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455375 ↗
• InjuryJan 22, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED APPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR A VENTRICULAR ARRHYTHMIA EPISODE, HOWEVER IT WAS STATED THAT THIS ACCELERATED THE RHYTHM. IT WAS NOTED THAT THE RHYTHM ENDED BY ITS OWN. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDE TROUBLESHOOTING OPTIONS, AS WELL AS RECOMMENDED TO HAVE A DEFIBRILLATION THRESHOLD (DFT) TEST. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 24148872 ↗
• MalfunctionJan 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ONE INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) DUE TO ATRIAL FLUTTER WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) REVIEWED AND NOTED NO NOISE OR IMPEDANCE MEASUREMENTS OUT OF RANGE WERE NOTED. TS WAS ALSO PROVIDED ALTERNATIVES WITH PROGRAMING THIS DEVICE INTO LEFT VENTRICULAR (LV) LEAD PACING ONLY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THE RIGHT VENTRICULAR (RV) LEAD OF THIS CRT-D SYSTEM EXHIBITED LOSS OF CAPTURE (LOC) DUE TO FRACTURE. SUBSEQUENTLY, REPROGRAMING WAS PERFORMED TO OBTAIN LEFT VENTRICULAR (LV) LEAD PACING ONLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24064119 ↗
• MalfunctionDec 24, 2025Signal Artifact/Noise; Failure to Read Input Signal; Under-Sensing; Low impedance; Device Sensing Problem; Signal Artifact/Noise; Failure to Read Input Signal; Under-Sensing; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS SYSTEM, WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD, DISPLAYED AN ALERT FOR THE RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) TEST IN PROGRAMMED AMPLITUDE OR SUSPENDED MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THIS WAS DUE TO NOISE. DURING DATA REVIEW, TS ALSO NOTED A GRADUAL DECREASE IN RV PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, ATRIAL UNDER SENSING WAS OBSERVED DUE TO THE AUTOMATIC GAIN CONTROL SENSITIVITY SETTINGS. TS RECOMMENDED FURTHER EVALUATION IN THE CLINIC. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890797 ↗
• MalfunctionDec 10, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE SIGNALS ON ALL CHANNELS. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED NOISE CAME FROM AN EXTERNAL SOURCE. NO OUT-OF-RANGE MEASUREMENT OR PAUSES IN PACING WERE NOTED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769772 ↗
• MalfunctionDec 8, 2025High impedance; High impedance

  IT WAS REPORTED DURING A ROUTINE DEVICE CHANGE OUT THE RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCE WAS OUT-OF-RANGE GREATER THAN 200 OHMS ON THIS NEWLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) WAS CONSULTED, AND TROUBLESHOOTING WAS PERFORMED AND THE BEHAVIOR IS SUSPECTED TO BE ISOLATED TO THE RA COIL AND NOT THE RV COIL. TS RECOMMENDED A DEFIBRILLATION THRESHOLD (DFT) TEST IN THIS NEW VECTOR. AT THIS TIME, THE LEAD AND DEVICE REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751753 ↗
• MalfunctionNov 7, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POTENTIALLY DELIVERED AN INAPPROPRIATE SHOCK THERAPY DURING A STENT PROCEDURE DUE TO OVERSENSING OF NOISY SIGNALS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED THE RV LEAD MEASUREMENTS REMAINED WITHIN NORMAL LIMITS AND STABLE OVER THE PAST YEAR, WITH NO EVIDENCE OF RV LEAD NOISE OUTSIDE THE PROCEDURE. ONE SHOCK WAS DELIVERED AND SUCCESSFULLY RESTORED SINUS RHYTHM. NO DEVICE MALFUNCTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499119 ↗
• InjuryAug 26, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE EMERGENCY ROOM (ER) WITH LOSS OF BRAIN FUNCTION. DEVICE DATA SHOWED APPROXIMATELY 26 SECONDS OF VENTRICULAR FIBRILLATION (VF); HOWEVER, UNDERSENSING WAS NOTED, SO THE TOTAL DURATION OF THE VF EPISODE IS UNKNOWN. A PAUSE GREATER THAN TWO SECONDS WAS ALSO OBSERVED, AND THE PATIENT WAS HOSPITALIZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Stroke/CVA

  MAUDE report 22898991 ↗
• MalfunctionAug 21, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CALLED TO REVIEW WITH TECHNICAL SERVICES (TS) THE POTENTIAL FOR INAPPROPRIATE SHOCK WITH TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION. THIS PATIENT THEN MENTIONED A FEW YEARS AGO THEIR IMPLANTED DEVICE SHOCKED THEM ACCIDENTALLY. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22864913 ↗
• MalfunctionAug 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS ALSO NOTED THE PATIENT IS AN ELDERLY PERSON AND THE DEVICE HAD BEEN SET TO MONITOR ONLY FOUR YEARS AGO. THE CLINIC IS EXPECTING TO CONTINUE TO MONITOR DUE TO DEVICE BEING SET TO MONITOR ONLY AND THE PATIENT AGE. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740243 ↗
• InjuryJun 18, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED SEVERAL ROUNDS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND IMPROPRIATE SHOCKS, THERAPY WAS EXHAUSTED, DUE TO AN EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE DEVICE DISPLAYED AN FC1005 CODE RELATED TO AN OPEN CIRCUIT. IT WAS DISCOVERED THAT GRADUAL SHOCK LEAD IMPEDANCE OUT OF RANGE AND HIGH THRESHOLDS WERE PRESENT, HOWEVER, THESE ISSUES WERE ASSOCIATED DIRECTLY TO THE RIGHT VENTRICULAR (RV) LEAD, WHICH WAS CAPPED AND REPLACED. THE CRTD REMAINS ACTIVE AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22288450 ↗
• MalfunctionJun 3, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM STORED VENTRICULAR EPISODES WITH NOISE ON THE RIGHT VENTRICULAR (RV) RATE/SENSE AND SHOCK CHANNELS. THE OBSERVED NOISE WAS OVERSENSED, WHICH LEAD TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND PACING INHIBITION FOR GREATER THAN TWO SECONDS. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC WITH THE PACING INHIBITION. UPON ELECTROGRAM (EGM) REVIEW, THE FINE NOISE APPEARED CYCLICAL, SUGGESTIVE OF EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) OR MUSCLE NOISE. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION; HOWEVER, THE NOISE WAS NOT REPRODUCIBLE VIA POCKET MANIPULATION OR ISOMETRICS. ADDITIONALLY, AN EMI SOURCE WAS NOT IDENTIFIED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, SUCH AS INCREASING THE AUTOMATIC GAIN CONTROL (AGC) OR CONSIDERING DEFIBRILLATION THRESHOLD (DFT) TESTING. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138438 ↗
• InjuryMay 27, 2025Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE AND SUSPECTED LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD CHANNEL. THE HEALTH CARE PROFESSIONAL PERFORMED AN IN-OFFICE EVALUATION AND NOTED CHANGES IN MORPHOLOGY DURING ISOMETRICS AS WELL AS PHRENIC NERVE STIMULATION IN CERTAIN PACING VECTORS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN OPTED TO TURN THE LEFT VENTRICULAR (LV) LEAD PACING OFF AND ALLOW INTRINSIC ACTIVITY TO OCCUR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22093226 ↗

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-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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, 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-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-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-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-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-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-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-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.