ENDOTAK RELIANCE® G 0175Recalls & reported problems

Summary

The FDA's MAUDE database contains 314 adverse event reports that list this exact device (DI 00802526373732), received between Jul 1, 2014 and Sep 9, 2026 — classified as 5 deaths, 171 injuries, 138 malfunctions.

The most frequently reported specific device problem is “High impedance” (215 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (P910073); 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.

Recalls naming this device

1. Jul 24, 2025Class IOpen, Classified

   Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

   Z-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 314 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695669 ↗
• MalfunctionAug 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133150 ↗
• InjuryJul 29, 2026High impedance; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted and replaced due to unknown reasons. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067668 ↗
• DeathJul 27, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited a gradual rise in shock impedance measurements within range. Technical Services (TS) was consulted and stated there were no out of range measurements observed. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002370 ↗
• MalfunctionJul 2, 2026Signal 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 25689918 ↗
• MalfunctionApr 30, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AND HIGH CAPTURE THRESHOLDS. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA, NOTED THIS RV LEAD WAS CONNECTED TO A NON-BOSTON SCIENTIFIC DEVICE AND RECOMMENDED TO REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050463 ↗
• MalfunctionApr 13, 2026Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW REPORTS ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED OVERSENSED NOISE ON A STORED VENTRICULAR EPISODES AND RIGHT VENTRICULAR (RV) INTRINSIC AMPLITUDE MEASUREMENTS OUT OF RANGE. TS SUSPECTED THE NOISE WAS FROM ELECTROMAGNETIC INTERFERENCE (EMI), AS THE PATIENT WAS CONFIRMED TO BE IN SURGERY WITH A MAGNET APPLIED AT THE TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865660 ↗
• InjuryMar 24, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING GRADUAL RISE IN SHOCK IMPEDANCES. THERE WERE NO OUT OF RANGE MEASUREMENTS, BUT THERE WAS A HIGH IMPEDANCE MEASUREMENT WHEN ATTEMPTING TO DELIVER A SHOCK. THERAPY WAS EXHAUSTED AND FAULT CODE 1005 WAS DISPLAYED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING RECOMMENDATIONS FOR THE LEAD AND DEVICE. SUBSEQUENTLY THIS RV LEAD WAS EXPLANTED AND REPLACED. THE ICD WAS EXPLANTED DUE TO THERAPY UPGRADE. THE RV LEAD HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678190 ↗
• MalfunctionMar 10, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED LOW AMPLITUDE AND NOISE, ALONG WITH LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AN INAPPROPRIATE SHOCK WAS DELIVERED DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. AFTER THIS, A CODE 1004 INDICATIVE OF A SHORT CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY WAS DISPLAYED. REPLACEMENT OF THE DEVICE AND LEAD WAS RECOMMENDED. ATHIS TIME, THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24562926 ↗
• MalfunctionFeb 9, 2026High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND NOTED TO HAVE RECORDED EPISODES OF SHOCK THERAPY. THE HEALTH CARE PROFESSIONAL (HCP) REVIEWED AN EPISODE AND OBSERVED THAT CODE 1005 HAD BEEN RECORDED. TECHNICAL SERVICES (TS) WAS CONTACTED FOR FURTHER REVIEW OF THE STORED DATA. TS REVIEWED THE PROVIDED DATA AND CONFIRMED THAT CODE 1005 WHICH INDICATED AN OPEN CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY WAS RECORDED. IT WAS NOTED THAT THE DEVICE HAD APPROPRIATELY DELIVERED A SHOCK TO CONVERT PATIENT RHYTHM, HOWEVER DURING THE DELIVERY OF THE SHOCK, HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCES THAT MEASURED TO BE GREATER THAN 125 OHMS WERE REPORTED. TS DISCUSSED POSSIBLE CAUSE AND RECOMMENDED FOR THE ICD AND RV LEAD TO BE REPLACED. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENT ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED DURING A FOLLOW UP VISIT, THE RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) WAS DETECTED TO BE GREATER THAN PROGRAMMED AMPLITUDE OR SUSPENDED. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS AND RECO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299000 ↗
• MalfunctionFeb 2, 2026High impedance

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, A RED ALERT WAS DISPLAYED ON THE DEVICE THAT INDICATED HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD WERE RECORDED. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW. TS REVIEWED THE DAILY THRESHOLD AND IMPEDANCE MEASUREMENTS TREND REPORT FINDINGS WITH THE HCP. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241839 ↗
• InjuryJan 12, 2026Failure to Capture; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO A PRODUCT PERFORMANCE ISSUE. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS REPLACED DUE TO EXHIBITING HIGH CAPTURES THRESHOLDS AND NO CAPTURE AT MAXIMUM OUTPUT. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045373 ↗
• MalfunctionDec 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS UP TO 126 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED BRINGING THE PATIENT INTO THE CLINIC FOR REPROGRAMMING. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928226 ↗
• MalfunctionDec 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY RISING SHOCK IMPEDANCE MEASUREMENTS REACHING OVER 200 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING CHANGES. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881397 ↗
• InjuryDec 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WILL NOT BE RETURNED, AS IT WAS DISCARDED AFTER EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750711 ↗
• InjuryOct 29, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. A REVISION PROCEDURE WAS PERFORMED AND THIS WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. FURTHER INFORMATION REGARDING PRODUCT RETURN STATUS HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420386 ↗
• InjurySep 24, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Failure to Convert Rhythm; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN PACING IMPEDANCE MEASUREMENTS. PACING IMPEDANCE MEASUREMENTS ARE NOW HIGH OUT OF RANGE. ADDITIONAL INFORMATION PROVIDED THIS RV LEAD WAS SUBSEQUENTLY EXPLANTED. ANOTHER RV LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THIS RV LEAD WAS FRACTURED. THE FRACTURE RESULTED IN REPRODUCIBLE NOISE WHICH WAS OVERSENSED. THE FIELD REPRESENTATIVE ALSO REPORTED THERE HAD BEEN NON-CONVERSION OF VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) DUE TO THIS RV LEAD FRACTURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THERE WAS NO EVIDENCE OF NON-CONVERSION OF VT OR VF. THIS RV LEAD HAS NOT BEEN RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23134244 ↗
• MalfunctionSep 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 186 OHMS. TECHNICAL SERVICES (TS) DISCUSSED THAT THERE WERE NO PROGRAMMING RECOMMENDATIONS AT THIS TIME AS THIS LEAD WAS CONNECTED TO A NON-BOSTON SCIENTIFIC DEVICE. TS RECOMMENDED TO CONTINUE TO MONITOR. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063349 ↗
• InjurySep 10, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO EXHIBITING HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN THE 120 OHM RANGE AND SLIGHTLY ELEVATED THRESHOLDS OF 1.5V. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016652 ↗
• InjuryAug 28, 2025High impedance; Failure to Convert Rhythm; High impedance; Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED A CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY. THE PATIENT EXPERIENCED A VENTRICULAR ARRHYTHMIA, DURING WHICH THERAPY WAS EXHAUSTED, BECAME UNRESPONSIVE, AND REQUIRED HOSPITALIZATION. THE PHYSICIAN ALLEGED THAT BIVENTRICULAR TRIGGER CAUSED THE ARREST. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE DEVICE DATA, NOTED SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS. TS EXPLAINED THAT THIS IS AN ADVISORY LEAD AND THE EIGHT SHOCKS DELIVERED WERE UNABLE TO CONVERT THE ARRHYTHMIA EPISODE. THE TIMING ON THE PREMATURE VENTRICULAR CONTRACTION (PVC) AND BIVENTRICULAR TRIGGER FELL AT THE END OF THE T-WAVE DEFLECTION APPEARED AS THE CAUSE OF THE VENTRICULAR FIBRILLATION (VF) ARREST. TS RECOMMENDED LEAD REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Loss of consciousness; Ventricular Fibrillation

  MAUDE report 22918155 ↗
• MalfunctionAug 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCES. THE HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE LEAD SHOCK IMPEDANCE VECTOR MEASURED TO BE GREATER THAN 125 OHMS WHICH IS CONSIDERED TO BE OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841621 ↗
• MalfunctionJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677418 ↗
• MalfunctionJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677386 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666850 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665633 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P910073. One submission often covers many models, so check the product and lot details in each record.

• Z-2326-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
• Z-2327-2025 · Jul 24, 2025 · Open, Classified
  RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692,