ENDOTAK RELIANCE® 0147Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00802526085789), received between Nov 27, 2018 and Sep 28, 2026 — classified as 2 deaths, 57 injuries, 19 malfunctions.

The most frequently reported specific device problem is “High impedance” (29 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Over-Sensing; Pacing Problem; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926081 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698454 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO EROSION AND INFECTION. THE PATIENT EXPERIENCED EDEMA, INFLAMMATION AND SWELLING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS CUT FROM THE TERMINAL PIN, AND THE LEAD BODY REMAINS IMPLANTED AND INACTIVE.

  Patient problems: Erosion; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25446911 ↗
• InjuryMar 4, 2026Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. A REVISION PROCEDURE WAS PERFORMED WHERE THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509927 ↗
• MalfunctionJan 7, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES. PACING INHIBITION OVER TWO SECONDS WAS ALSO OBSERVED. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW DISCUSSED IT APPEARS TO BE ELECTROMAGNETIC INTERFERENCE (EMI). CLINICAL EVALUATION WILL BE PERFORMED. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 23991396 ↗
• InjuryNov 7, 2025Signal Artifact/Noise; Defective Device; Signal Artifact/Noise; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER RV LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THIS LEAD WAS SURGICALLY ABANDONED DUE TO NOISE EXHIBITED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500615 ↗
• InjuryJul 3, 2025Adverse 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 REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22401114 ↗
• InjuryApr 17, 2025High impedance; High impedance

  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 21862309 ↗
• MalfunctionMar 18, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP. UPON EXAMINATION, AN EPISODE OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS OBSERVED DUE TO OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. PROGRAMMING CHANGES WERE MADE TO ADDRESS THE OVERSENSING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632669 ↗
• MalfunctionFeb 27, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED MYOPOTENTIAL NOISE OVERSENSING. FURTHER TESTING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21482327 ↗
• MalfunctionFeb 3, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD A RISE IN THE PACING AND SHOCK IMPEDANCES THEN A SHARP DROP. PRIOR TO THE DROP THE IMPEDANCE MEASUREMENTS WERE OVER 2000 OHMS. TECHNICAL SERVICES (TS) NOTED NO OVERSENSING. THE REPRESENTATIVE IS PLANNING TO CHECK IF THE PATIENT HAD A PROCEDURE AT THE TIME OF THE EVENT. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296214 ↗
• MalfunctionOct 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED DUE TO NORMAL BATTERY DEPLETION (NBD) AND THE PHYSICIAN OPTED TO KEEP THIS RV LEAD ACTIVE AND IN SERVICE. GOOD SENSING AND THRESHOLDS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510808 ↗
• InjuryOct 14, 2024Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WITH LOSS OF CAPTURE (LOC). A LEAD REVISION WAS PERFORMED. SHOCK IMPEDANCE MEASUREMENTS WERE IN RANGE; THEREFORE, THE RATE SENSE TERMINAL WAS CAPPED, AND A NEW RV RATE SENSE LEAD WAS SUCCESSFULLY PLACED. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439386 ↗
• InjuryJul 24, 2024Adverse 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 EXPLANTED TO UNKNOWN ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813426 ↗
• InjuryJul 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS BEING EXPLANTED DURING A DEVICE CHANGEOUT PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN "TORE EVERYTHING". THE LEAD FELL APART WHILE BEING EXTRACTED AND A PIECE OF METAL FELL INTO THE PATIENT'S LUNG. ANOTHER PROCEDURE WAS DONE SEVERAL DAYS LATER TO RETRIEVE THE PIECE OF METAL. THE PIECE OF METAL WAS DEDUCED BY TECHNICAL SERVICES (TS) TO BE A METAL RING THAT CONNECTED THAT LEAD TO THE COIL. THE LEAD WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19650538 ↗
• MalfunctionJun 21, 2024Signal Artifact/Noise; Fracture; Over-Sensing; Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IS DAMAGED IN THE PACE SENCE CONDUCTOR AND NON PHYSIOLOGIC NOISE OVER SENSED. RV REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581505 ↗
• InjuryApr 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD GRADUALLY INCREASED AND REACHED OUT OF RANGE MEASUREMENTS OF 2000 OHMS. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050778 ↗
• InjuryFeb 28, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXHIBITING HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS ABOVE 2500 OHMS AND HIGH CAPTURE THRESHOLDS. BRADY PACING WAS TURNED OFF. THIS ICD SYSTEM REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796664 ↗
• InjuryFeb 22, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT AFTER 22 YEARS IN SERVICE THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED NOISY SIGNALS, SO IT WAS CAPPED AND SURGICALLY ABANDONED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763565 ↗
• MalfunctionDec 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274049 ↗
• InjuryNov 20, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE BOSTON SCIENTIFIC REPRESENTATIVE HAD CALLED FOR THE REVIEW OF THE PRESENTING AND QUESTIONED ABOUT NOISY SIGNALS ON THIS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) AGREED THAT THERE WAS NOISE PRESENT AND RWAVES WERE NOT LOOKING GOOD. SUBSEQUENTLY THIS LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD WAS IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169904 ↗
• InjuryOct 18, 2023Fracture; Defective Device; Fracture; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. THIS LEAD HAD A FRACTURE AND WAS SHREDDED DURING EXPLANT PROCESS. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958238 ↗
• InjuryJul 26, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT, THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO HIGH PACING IMPEDANCES OUT OF RANGE AND HIGH PACING THRESHOLDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398081 ↗
• InjuryJul 20, 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 BACTEREMIA. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE BACTEREMIA CAUSED ENDOCARDITIS WITH VEGETATION THAT AFFECTED A LEAD. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 17365615 ↗
• InjuryJun 22, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183124 ↗

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,