ENDOTAK RELIANCE® 0158Recalls & reported problems

Summary

The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 00802526531132), received between Nov 9, 2015 and Sep 26, 2026 — classified as 1 death, 261 injuries, 69 malfunctions.

The most frequently reported specific device problem is “High impedance” (97 reports).

3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906402 ↗
• MalfunctionAug 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. FURTHER MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911173 ↗
• MalfunctionJul 18, 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) EXHIBITED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL, WHICH CAUSED PACING INHIBITION WITH FIVE SECONDS OF ASYSTOLE. AN IN-OFFICE EVALUATION WAS PERFORMED IN WHICH MYOPOTENTIAL NOISE COULD BE OBSERVED, HOWEVER THE OVERSENSING WAS NOT REPRODUCED. TECHNICAL SERVICES (TS) WAS CONSULTED AND POSSIBLE CAUSES FOR THE NOISE WERE DISCUSSED. TS ADVISED ON FURTHER EVALUATION OF THE LEAD. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 22543440 ↗
• MalfunctionAug 5, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE REPRESENTATIVE DISCUSSED THAT IF THE DEVICE IS PROGRAMMED RV COIL TO CAN THE MEASUREMENTS ARE LOW BUT WITHIN RANGE. TECHNICAL SERVICES (TS) IT WAS PHYSICIAN DISCRETION BUT SINCE GETTING IN RANGE VALUES IN RV COIL TO CAN SHOULD CONSIDER PROGRAMMING TO THIS VECTOR. THE POSSIBILITY OF A DEFIBRILLATION THRESHOLD (DFT) TEST WAS DISCUSSED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905971 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17219831 ↗
• MalfunctionJun 15, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR CHANNEL. NO CHANGES HAVE BEEN PERFORMED SINCE THE SIGNAL FALL INTO BLANKING. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140686 ↗
• InjuryMay 31, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE PACE AND SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED. THIS LEAD REMAINS IN SERVICE AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034801 ↗
• InjuryMay 19, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLD. MOREOVER, THE PHYSICIAN SUSPECTED THAT THE GROWTH OF CHRONIC TISSUE AROUND THE LEAD CAUSED THE INCREASE IN THRESHOLD. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968174 ↗
• InjuryMay 3, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLDS. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865803 ↗
• InjuryMay 2, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD. THIS LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854568 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16822769 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16812398 ↗
• MalfunctionApr 25, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS. IT WAS NOTED THAT THERE WAS AN INCREASE APPROXIMATELY 5 MONTHS PRIOR. TECHNICAL SERVICES (TS) NOTED PHYSICIAN DISCRETION WHETHER A COMMANDED SHOCK SHOULD BE PERFORMED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809582 ↗
• InjuryApr 18, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED DURING GENERATOR CHANGE OUT PROCEDURE FOR LOW R-WAVE AMPLITUDES. ANOTHER RV LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763344 ↗
• MalfunctionApr 11, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THERE WERE OBSERVATIONS OF HIGH, OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 200 OHMS. IT WAS NOTED THERE WERE NO ISSUE WITH THE PREVIOUS DEVICE. THE DEVICE WAS THEN REMOVED FROM THE POCKET AND A TUG TEST WAS PERFORMED IN WHICH THEY PULLED THE PIN OUT OF THE HEADER AND RECONNECTED IT AND SHOCK IMPEDANCE MEASUREMENTS WERE ALL WITHIN NORMAL RANGE. THE ICD AND RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717425 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16694287 ↗
• InjuryMar 22, 2023High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD RECENTLY UNDERWENT A DEVICE REPLACEMENT PROCEDURE, AND THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS POSITIONED ON THE RIGHT SIDE. ALL RV LEAD MEASUREMENTS AFTER IMPLANT WERE FINE. IT WAS NOTED THAT THE IMPLANTING PHYSICIAN STRUGGLED TO GET THE PREVIOUS DEVICE OUT OF THE POCKET AND MAKE THE LEADS FREE ENOUGH TO CONNECT EVERYTHING AGAIN. THE PHYSICIAN WAS VERY THOROUGH, AND EVEN CONNECTED THE SHOCK COIL TWICE IN ORDER TO VERIFY INSERTION. THE NEXT MORNING, THE SHOCK IMPEDANCE WAS OBSERVED TO BE GREATER THAN 200 OHMS. TECHNICAL SERVICES WAS CONSULTED AND REVIEWED BOTH DEVICE DATA AND AVAILABLE IMAGES, AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS RECOMMENDED. THE FOLLOWING WEEK, DFT WAS PERFORMED AND WAS SUCCESSFUL. THIS RV LEAD REMAINS IN SERVICE, AND THERE WERE NO ASSOCIATED PATIENT SYMPTOMS REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594956 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16478163 ↗
• InjuryFeb 25, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO NOISY SIGNALS OVERSENSING. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441062 ↗
• InjuryFeb 23, 2023Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD EXHIBITED LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS AND HIGH THRESHOLD WITH INTERMITTENT CAPTURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. DURING THE EXPLANT OF THE DEVICE, WHEN THE DEVICE WAS BEING REMOVED FROM THE POCKET IT WAS NOTED THE LV LEAD WAS FRACTURED AT THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV AND RV LEAD WERE SURGICALLY ABANDONED. THE DEVICE AND THE BROKEN LEAD WILL BE SENT BACK FOR DEVICE ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426562 ↗
• InjuryFeb 15, 2023Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, NOISE AND OVERSENSING. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD AND DEVICE WERE ABANDONED. A NEW LEAD AND DEVICE WERE IMPLANTED IN THE LEFT SIDE OF THE CHEST. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381067 ↗
• InjuryFeb 14, 2023Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO HIGH IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC). NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375973 ↗
• InjuryFeb 13, 2023Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH IMPEDANCE ISSUES. IT WAS CONFIRMED THAT THE LEAD WAS FRACTURED. A NEW RV WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16365524 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 16292546 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16256277 ↗

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-2325-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o18
• 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,