ENDOTAK RELIANCE® 0276Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00802526531231), received between Jul 11, 2017 and Jul 1, 2026 — classified as 2 deaths, 55 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (14 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 74 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25676737 ↗
• InjuryFeb 9, 2026Defibrillation/Stimulation Problem; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. ANOTHER RV LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298242 ↗
• InjuryAug 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLDS. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814338 ↗
• InjuryJun 26, 2025Signal Artifact/Noise; Defective Device; Material Integrity Problem; Signal Artifact/Noise; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO INSULATION BREACH FOUND WHEN POCKET WAS OPENED FOR EXTRACTION. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333956 ↗
• MalfunctionDec 9, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STORED VENTRICULAR EPISODES DUE TO CONCERNS OF OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. UPON REVIEW OF THE STORED VENTRICULAR EPISODE, TS OBSERVED THAT ON THE RIGHT ATRIAL (RA) CHANNEL, THE PATIENT APPEARED TO BE IN AN ATRIAL FLUTTER (AF) ARRHYTHMIA. FURTHER REVIEW OF THE EPISODES, TS DETERMINED THAT THERE WAS CROSSTALK OVERSENSING OF THE AF ON THE RV LEAD. THE HCP NOTED THAT THE PATIENT IS ON ANTIARRHYTHMIC MEDICATION TO TREAT THE PATIENT UNDERLYING ARRHYTHMIA AND HAS BEEN IN NORMAL SINUS SINCE THE VENTRICULAR EPISODE. TS DISCUSSED REPROGRAMMING OPTIONS WITH THE HCP. AT THIS TIME, THE CRT-D AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879232 ↗
• InjuryOct 8, 2024Signal Artifact/Noise; Fracture; Impedance Problem; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED NOISE AND IMPEDANCE ISSUE. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402645 ↗
• DeathOct 3, 2024Signal Artifact/Noise; High impedance; Low impedance; Signal Artifact/Noise; High impedance; Low impedance

  IT WAS REPORTED THAT THE ICD SYSTEM EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE, FREQUENTLY GREATER THAN 200 OHMS. BOTH THE RV COIL TO RA COIL AND RA COIL TO CAN VECTORS MEASURED GREATER THAN 200 OHMS, WHILE THE RV COIL TO CAN CONFIGURATION MEASURED 60 OHMS. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED NOISE AND FREQUENT LOW PACE IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. THE NOISE WAS REPRODUCIBLE ON BOTH THE RV AND SHOCK CHANNELS. THE ICD SYSTEM WAS PROGRAMMED IN THE RV COIL TO CAN CONFIGURATION AND TECHNICAL SERVICES DISCUSSED FURTHER TROUBLESHOOTING. NO ACCIDENTS, FALLS, PROCEDURES WERE KNOWN TO HAVE OCCURRED THAT COULD HAVE INFLUENCED THE MEASUREMENTS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED DURING AN RV REVISION/EXPLANT PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS STATED THAT THE PHYSICIAN DID NOT FEEL THAT THE DEVICE OR PROCEDURE CONTRIBUTED TO THE PATIENT'S DEATH; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE LEAD WAS RETAINED BY THE FACILITY AND IS NOT EXPECTED TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365132 ↗
• InjuryJun 20, 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 PART OF A SYSTEM REVISION DUE TO SUSPECTED VEGETATION ON LEADS. THE PHYSICIAN INTENDS TO REMOVE THE SYSTEM AND INSTALL A DUAL-CHAMBER PACEMAKER TO ADDRESS ATRIAL FIBRILLATION, WITH PLANS TO SET VENTRICULAR BACKUP PACING AT 40 BEATS PER MINUTE. ADDITIONALLY, THE OPTION OF PROGRAMMING THE RA LEAD-OFF IS BEING CONSIDERED. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. TIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 19575566 ↗
• MalfunctionMay 6, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE (LOC). IT WAS NOTED THAT THE PATIENT HAD AN UNDERLYING RHYTHM. TECHNICAL SERVICES (TS) DISCUSSED WITH THE PHYSICIAN NOT LETTING THE PATIENT GO HOME UNTIL THE OUTPUT IS ADJUSTED. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19253614 ↗
• InjuryApr 25, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO HIGH PACING THRESHOLDS. A NEW RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181845 ↗
• MalfunctionApr 3, 2024Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAX CAPTURE OUTPUT. ADDITIONALLY, THE LEAD EXHIBITED HIGH WITHIN RANGE PACING IMPEDANCE. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THE IMPEDANCE STARTED TO SLOWLY INCREASE FOR APPROXIMATELY SEVEN MONTHS. TS PROVIDED A POTENTIAL CAUSE AND ADVISED THEY COULD CONTINUE TO MONITOR THE ISSUE, BUT ULTIMATELY IT WAS PHYSICIAN DISCRETION. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033538 ↗
• MalfunctionJan 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. FURTHER EVALUATION OF THE PATIENT WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451679 ↗
• InjuryNov 2, 2023Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED DUE TO LOSS OF CAPTURE (LOC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD LOSS OF CAPTURE (LOC) WAS CONFIRMED WITH THRESHOLD TESTING AND X-RAYS, PRIOR TO LEAD REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD IS EXPECTED TO BE RETURNED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062256 ↗
• InjuryOct 19, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISY SIGNALS WHILE THE PACEMAKER WAS IN SAFETY MODE. THE NOISY SIGNALS WERE ATTRIBUTED TO MYOPOTENTIAL NOISE. AS A RESULT, THERE WAS PACING INHIBITION THAT RESULTED IN A SYNCOPAL EPISODE FOR THIS PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 17970425 ↗
• MalfunctionSep 12, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS EVALUATED IN OFFICE WITH ISOMETRICS AND OUT OF RANGE MEASUREMENTS WERE OBTAINED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE POSSIBILITY OF A LEAD FRACTURE. REPROGRAMMING OPTIONS WERE DISCUSSED AND FURTHER EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732802 ↗
• 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17362821 ↗
• InjuryJul 11, 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 17302212 ↗
• MalfunctionJul 7, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Defective Device; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED SIGNIFICANT NOISE WITH OVERSENSING SINCE DECEMBER 2016, RESULTING IN AN INAPPROPRIATE SHOCK AND INAPPROPRIATE ATP. MORE RECENTLY, THIS OVERSENSED NOISE RESULTED IN AN INAPPROPRIATE BURST OF ATP AND GREATER THAN TWO SECONDS OF PACING INHIBITION. IT WAS UNCLEAR WHETHER THE PATIENT WAS PACER DEPENDENT AS THE DEVICE RV PACED 1%. TECHNICAL SERVICES (TS) REVIEWED POSSIBLE CAUSES AND TROUBLESHOOTING OPTIONS, AND POSSIBLE LEAD INTEGRITY CONCERNS WERE DISCUSSED. THIS ICD SYSTEM REMAINS IN SERVICE, HOWEVER FURTHER EVALUATION WAS RECOMMENDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17278898 ↗
• InjuryJun 22, 2023Low impedance; Defective Device; Low impedance; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PRESENTING LOW IMPEDANCE MEASUREMENTS AND AN INSULATION BREACH WAS SUSPECTED, SO IT WAS CAPPED AND SURGICALLY ABANDONED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181636 ↗
• InjuryMay 23, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO IT WAS DETERMINED VIA ROUTINE FOLLOW UP TO THE DEVICE CLINIC THAT THE DEVICE OF THIS PATIENT WAS RECORDING NONSUSTAINED TACHY EPISODES ASSOCIATED WITH NONPHYSIOLOGIC NOISE ON THE RV PACE SENSE CHANNEL. A FLUOROSCOPY OF THE EXISTING LEAD WAS PERFORMED. NO INAPPROPRIATE THERAPY WAS DELIVERED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984520 ↗
• InjuryApr 18, 2023Failure to Capture; Failure to Read Input Signal; Low impedance; Device Sensing Problem; Failure to Capture; Failure to Read Input Signal; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN LEFT VENTRICULAR ASSIST DEVICE (LVAD) PROCEDURE AND PRESENTED TO THEIR HEALTH CARE FACILITY FOR ROUTINE FOLLOW UP POST LVAD PROCEDURE. UPON DEVICE INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE, LOW R WAVE AMPLITUDES AND WITHIN RANGE IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE PATIENT HAS INTERMITTENT HEART BLOCK WITH AND UNDERLYING HEART RATE IN THE 60S. ADDITIONALLY, DEVICE FEATURE, RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) HAD STOPPED TAKING MEASUREMENTS POST LVAD PROCEDURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING AND PROGRAMMING RECOMMENDATIONS. AN X-RAY WAS RECOMMENDED TO ASSESS DEVICE AND LEAD PLACEMENT. SUBSEQUENTLY, THE DEVICE WAS REPROGRAMMED DURING THE OFFICE VISIT AND THE HCP WAS GOING TO FOLLOW UP WITH THE IMPLANTING PHYSICIAN REGARDING NEXT STEPS. AT THIS TIME, THE ICD AND THE RV LEAD HAVE BEEN EXPLANTED AT A SURGICAL PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760293 ↗
• MalfunctionJan 9, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) EXHIBITED NOISY SIGNALS OVERSENSING AND PACING INHIBITION, LEADING INTO AN ASYSTOLE GREATER THAN TWO SECONDS. ADDITIONALLY, TECHNICAL SERVICES DISCUSSED THE RV AUTOMATIC THRESHOLD (RVAT) FEATURE WAS IN SUSPENSION. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Asystole

  MAUDE report 16125969 ↗
• InjuryDec 22, 2022Signal 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) SYSTEM EXHIBITED NOISY SIGNALS, OVERSENSING LEADING INTO INAPPROPRIATE THERAPY ON THIS RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY THIS RV LEAD WAS SCHEDULED TO BE REVISED. FURTHERMORE, THE WHOLE SYSTEM WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; Unspecified Infection

  MAUDE report 16038586 ↗
• InjuryNov 4, 2022Adverse 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. REPORTEDLY, THE PATIENT HAD BACTEREMIA STATUS POST SURGICAL SITE INFECTION RELATED TO MVA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 15730578 ↗
• InjuryOct 17, 2022Adverse 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 15619462 ↗

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,