INCEPTA™ ICD E163Recalls & reported problems

Summary

The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 00802526480782), received between Mar 22, 2018 and Sep 16, 2026 — classified as 1 death, 250 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (142 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) had a magnet applied during a procedure. Following the procedure, Technical Services (TS) was consulted to evaluate device performance. TS reviewed the available data and confirmed that the device appeared to be functioning as programmed and expected. TS noted the presence of stored noise events that correlated with magnet application; however, no device-related issues or complications were identified. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783366 ↗
• MalfunctionJul 8, 2026Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW R-WAVES. IT WAS ALSO NOTED THAT THERE WERE NOISY SIGNALS ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD CHANNELS, AS WELL AS, ON THE SHOCK ELECTROGRAM (EGM). THE RA AND RV LEADS ARE NON-BOSTON SCIENTIFIC PRODUCTS. THE NOISE WAS OVERSENSED ON THE RA LEAD CHANNEL. TECHNICAL SERVICES (TS) SUGGESTED TROUBLESHOOTING ACTIONS. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25749481 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25286889 ↗
• InjuryMay 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Defibrillation/Stimulation Problem; Low impedance; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO NOT HAVE DELIVERED A SHOCK FOR VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS FOUND UNRESPONSIVE IN THEIR CAR. UPON, INTERROGATION FAULT CODES 1004 AND 1007 WERE FOUND. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY THIS ICD SYSTEM WAS EXPLANTED AND REPLACED. THIS ICD HAS BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Loss of consciousness; Syncope/Fainting

  MAUDE report 25164853 ↗
• MalfunctionMay 6, 2026Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE AROUND 10 OHMS DURING A DEVICE REPLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, THE SHOCK IMPEDANCE MEASUREMENTS WERE IN RANGE. TECHNICAL SERVICES (TS) SUSPECTED DUE TO THE AGE OF THE LEAD; IT WAS POSSIBLE THE INSULATION WAS BREAKING DOWN. TS DISCUSSED IF INSULATION WAS NOT INTACT, THE DEVICE COULD HAVE ISSUES CONVERTING ARRYTHMIAS. TS RECOMMENDED PERFORMING A LEAD REVISION. THIS ICD WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE NON-BOSTON SCIENTIFIC LEAD REMAINS IN SERVICE. IT WAS REPORTED THERE WAS A DELAY IN PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095760 ↗
• MalfunctionFeb 19, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A RED ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THIS ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388587 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24313008 ↗
• MalfunctionFeb 10, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISY SIGNALS ON BOTH THE RIGHT ATRIAL (RA) CHANNEL AND HIGH VOLTAGE (HV) SHOCK CHANNEL, AS WELL AS OVERSENSING ON THE RA CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE LEAD DIAGNOSTICS, WHICH SHOWED VALUES WITHIN NORMAL LIMITS. TS RECOMMENDED AN IN PERSON FOLLOW UP EVALUATION FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304123 ↗
• InjuryJan 28, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED POSSIBLE TROUBLESHOOTING OPTIONS. THIS ICD WAS SUBSEQUENTLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205895 ↗
• MalfunctionJan 21, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT A BOSTON SCIENTIFIC PRODUCT. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130084 ↗
• InjuryJan 12, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED ANTI-TACHYCARDIA PACING (ATP) DUE TO ATRIAL DRIVEN RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW, IDENTIFIED NOISE IN THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS WITH OVERSENSING OF THE VENTRICLE. THEREFORE, RA AND RV LEAD ISSUES WERE SUSPECTED. IN ADDITION, TS DISCUSSED THAT THE DEVICE IS FUNCTIONING AS PROGRAMMED AND THAT THE ATP THERAPY WAS INAPPROPRIATE. THIS SYSTEM WAS TURNED OFF AND SURGICALLY ABANDONED, AND A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037076 ↗
• InjuryDec 31, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME GREATER THAN 15 SECONDS DURING A VENTRICULAR FIBRILLATION EPISODE. DESPITE THIS, ANTI TACHYCARDIA PACING AND A SHOCK WERE DELIVERED, CONVERTING THE RHYTHM SUCCESSFULLY. THE CHARGE TIME DURING CAPACITOR REFORMATION WAS WITHIN ACCEPTABLE LIMITS. TECHNICAL SERVICES WAS CONSULTED AND INDICATED IT WAS PHYSICIAN DISCRETION TO CONSIDER DEVICE REPLACEMENT BEFORE REACHING ELECTIVE REPLACEMENT INDICATOR BASED ON CHARGE TIME FROM THE PRESENTED EPISODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23934143 ↗
• InjuryDec 24, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSED NOISY SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED NOISE AND OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL ON THE STORED ATRIAL TACHY RESPONSE (ATR) EPISODES. SUBSEQUENTLY, THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PHYSICIAN DECIDED TO MAINTAIN THE RA LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888799 ↗
• InjuryDec 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS-1 TERMINAL PIN AND SCREW WOULD NOT CONNECT ON RIGHT VENTRICULAR (RV) LEAD. THE FIELD REPRESENTATIVE REPORTED THIS ICD WAS NOT SUCCESSFULLY IMPLANTED BECAUSE THE LOCKING MECHANISM ON THE HEADER WAS NOT WORKING PROPERLY. IN ADDITION, THE SET SCREW WOULD NOT CONNECT TO THE RIGHT VENTRICULAR LEAD. ANOTHER ICD WAS ATTEMPTED USING A LEAD EXTENDER AND WAS SUCCESSFUL. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812331 ↗
• MalfunctionDec 1, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTING ELECTROGRAM (EGM). UPON REVIEW, THE PRESENTING EGM SHOWED MYOPOTENTIAL OVERSENSING NOISE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD CHANNELS. TS PROVIDED PROGRAMMING AND LEAD REVISION RECOMMENDATIONS. IT WAS NOTED THAT THE RA LEAD IS A NON-BOSTON SCIENTIFIC LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD AND BOTH LEADS REMAIN IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688444 ↗
• MalfunctionSep 11, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECENTLY PASSED AWAY IN HOSPICE. PRIOR TO THE PATIENT'S DEATH, MULTIPLE APPROPRIATE SHOCKS WERE DELIVERED. THE PATIENT ADVOCATE REQUESTED THAT DEVICE THERAPY BE TURNED OFF FOR PATIENT COMFORT. UPON REVIEW, THE PHYSICIAN WAS CONCERNED ABOUT POTENTIAL PREMATURE BATTERY DEPLETION, AS THE BATTERY WAS DIMINISHING FASTER THAN NORMAL. AT THIS TIME, THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027958 ↗
• InjuryAug 14, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DELIVERED AN APPROPRIATE SHOCK RESULTING IN A RECORDED CODE 1005. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806837 ↗
• MalfunctionJul 31, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE OVERSENSING ON BOTH RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CHANNELS, LEADING TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SINGLE SHOCK DELIVERY. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW IT WAS NOTED THAT THE NOISE WAS CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI). TECHNICAL SERVICES (TS) RECOMMENDED MAGNET PLACEMENT DURING SURGICAL PROCEDURES TO PREVENT INAPPROPRIATE THERAPY OR EVALUATING EMI SOURCES IN THE HOUSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22675776 ↗
• MalfunctionJul 24, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) REGARDING A CONSULT TRANSMISSION FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE DETECTED A RHYTHM IN THE VENTRICULAR FIBRILLATION (VF) ZONE AND DELIVERED QUICK CONVERT ANTI-TACHYCARDIA PACING (ATP), WHICH BRIEFLY TERMINATED THE ARRHYTHMIA. HOWEVER, THE RHYTHM SPONTANEOUSLY RECURRED, PROMPTING THE DEVICE TO INITIATE CHARGING. BEFORE SHOCK DELIVERY, THE RHYTHM SELF-TERMINATED, BUT THE SHOCK WAS COMMITTED AND DELIVERED WHILE THE PATIENT WAS IN NORMAL SINUS RHYTHM. THE DEVICE ACCURATELY SENSED THE RHYTHM THROUGHOUT THE EPISODE. THE INAPPROPRIATE SHOCK WAS ATTRIBUTED TO DEVICE TIMING AND PROGRAMMING LOGIC. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22588616 ↗
• MalfunctionJun 30, 2025Over-Sensing; Pacing Problem; Failure to Read Input Signal; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE WAS CONTACTED BY THE HEALTH CARE PROFESSIONAL (HCP) WHO REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) BURST DUE TO T WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED FOR FURTHER REVIEW OF THE STORED EPISODE. IT WAS NOTED THAT THE RV LEAD IS A NON-BOSTON SCIENTIFIC LEAD. TS REVIEWED THE PROVIDED DATA AND CONFIRMED THE INAPPROPRIATE ATP. TS ALSO NOTED THAT THE PATIENT APPEARED TO HAVE HIGH SINUS RATES AND A DECREASE IN R WAVE AMPLITUDES. TS DISCUSSED POSSIBLE FINDINGS WITH THE FIELD REPRESENTATIVE AND RECOMMENDED AN IN PERSON VISIT FOR FURTHER EVALUATION. SUBSEQUENTLY, THE FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN WILL REPROGRAM THE DEVICE SETTINGS AND WILL CONTINUE TO MONITOR AT THIS TIME. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENT ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT DURING A FOLLOW UP VISIT, THE ICD SYSTEM WAS EVALUATED, AND THE LEAD MEASUREMENTS WERE FOUND TO BE NORMAL WITH GOOD SENSING MEASUREMENTS. IT WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367476 ↗
• InjuryJun 2, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL, WHICH LED TO INAPPROPRIATE SHOCK THERAPY DELIVERY IN SEVERAL INSTANCES. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED FURTHER REVIEW OF THE RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22129203 ↗
• InjuryMay 5, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE THAT WAS OVERSENSED DURING WHAT APPEARED TO BE A PROCEDURE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 21961020 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21882353 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862013 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THE ASSOCIATED RV LEAD WAS TAKEN OUT OF SERVICE; HOWEVER, THIS DEVICE REMAINED IN SERVICE AT THE TIME OF PROCEDURE AND WAS SUBSEQUENTLY REMOVED FROM SERVICE AT A LATER DATE TO AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857232 ↗

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-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• 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-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-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