ENDOTAK RELIANCE® S 640262-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00802526601828), received between Apr 24, 2019 and Feb 26, 2025 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “High impedance” (8 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 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 THE SYSTEM REVISION DUE TO BACTERIAL INFECTION AND SEPSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 21468192 ↗
• MalfunctionDec 12, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED AN ALERT DUE TO AN OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT HOWEVER, NO VALUE WAS DISPLAYED. TECHNICAL SERVICES (TS) DISCUSSED THE 24-HOUR CLOCK AND INFORMED PACING LEAD IMPEDANCES HAVE MEASURED AN AVERAGE OF 1,900 OHMS. NORMAL RANGE FOR THIS LEAD IS 1,800 OHMS. TS REVIEWED THE LOGBOOK AND THERE IS NO EVIDENCE OF NOISE. TS RECOMMENDED AN IN-CLINIC INTERROGATION TO RESET THE ALERT AND TO CONSIDER RAISING THE UPPER LIMIT TO 2,250 OHMS IF CLINICALLY APPROPRIATE. ADDITIONALLY, ISOMETRICS WAS RECOMMENDED. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914268 ↗
• InjuryNov 14, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD. THIS RV LEAD WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685847 ↗
• InjuryOct 25, 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 INFECTION. IT WAS PRESENTED WITH INFECTED INCISION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20536504 ↗
• MalfunctionAug 9, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RECENTLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE AND OVERSENSING ON THIS RIGHT VENTRICULAR (RV) LEAD. IT WAS BELIEVED TO BE DUE TO AIR ESCAPING FROM THE HEADER OF THE DEVICE. TECHNICAL SERVICES (TS) CONFIRMED THERE WAS ONE EPISODE OF OVERSENSING THAT RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY, BRADYCARDIA AND PACING INHIBITION. FURTHER SYSTEM EVALUATION WAS PLANNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT CONFIRMED THE ROOT CAUSE OF THE NOISE WAS AIR ESCAPING FROM THE HEADER OF THE DEVICE. IT WAS NOTED NO FURTHER EVENTS WERE REPORTED AND NO FUTURE EVALUATION IS EXPECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Bradycardia

  MAUDE report 19952274 ↗
• InjuryApr 22, 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 DUE TO UNKNOWN ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 19150382 ↗
• MalfunctionMar 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS A RED ALERT DUE TO HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. AT THIS TIME, THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839352 ↗
• InjuryOct 20, 2023Failure to Convert Rhythm; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED TECHNICAL SERVICES (TS) REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DATA TO CONFIRM DEVICE OPERATION. THE HCP REPORTED THAT MULTIPLE EPISODES OF BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS WERE DELIVERED APPROPRIATELY DUE TO VENTRICULAR ARRYTHMIA. THE SHOCKS AND ATPS THERAPIES WERE UNABLE TO CONVERT THE ARRYTHMIA, WITH AN EPISODE THAT RECORDED THIS ICD DEVICE TO HAVE DELIVERED ALL ITS PROGRAMMED THERAPY. IT WAS ALSO NOTED THAT DURING A DEFIBRILLATION THRESHOLD (DFT) TEST PERFORMED HAD DIFFICULTIES CONVERTING THE RHYTHM. THE ICD AND LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17980689 ↗
• MalfunctionAug 17, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED AMPLITUDE AND THRESHOLDS WERE WITHIN LIMIT. REPROGRAMMING OPTIONS WERE DISCUSSED. 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 17565983 ↗
• MalfunctionApr 25, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING PACING LEAD IMPEDANCE MEASUREMENTS SHORTLY AFTER IMPLANT, INCLUDING MEASUREMENT UP TO 2300 OHMS, WHICH WAS OUT-OF-RANGE. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING INCLUDING RECOMMENDING FURTHER MONITORING. NO FURTHER ACTION OR INTERVENTION HAS BEEN PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808324 ↗
• InjuryMar 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED SINCE IT WAS DAMAGED DURING A LEFT VENTRICULAR ASSIST DEVICE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16614902 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE EXPLANTED DUE TO SUSPECTED PERFORATION. IT IS UNKNOWN WHAT LEAD HAD PERFORATED THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD PERICARDIAL EFFUSION A FEW DAYS PRIOR TO THE EXPLANT. BOTH LEADS WERE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEADS REMAIN IN HOSPITAL POSSESSION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 15808408 ↗
• InjuryJul 20, 2022Defibrillation/Stimulation Problem; Failure to Read Input Signal; Under-Sensing; Defibrillation/Stimulation Problem; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW AMPLITUDE AND UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. WHICH LED TO A DELAY IN THE THERAPY. SUBSEQUENTLY, THE RV LEAD WAS NOT SUCCESSFULLY IMPLANTED. THIS RV LEAD WAS NEVER IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064453 ↗
• InjuryMay 28, 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14538347 ↗
• MalfunctionMay 28, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS APPROXIMATELY 3 WEEKS POST IMPLANT. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS WITH THE HEALTH CARE PROFESSIONAL. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14536846 ↗
• InjuryOct 12, 2021Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REVISED DUE TO HIGH PACING THRESHOLD. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF HIGH PACING THRESHOLD WAS MICRO DISLODGEMENT. THE LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620235 ↗
• InjuryJul 23, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS RECENTLY IMPLANTED RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED LOSS OF CAPTURE AT THE PRE-DISCHARGE CHECK, HOWEVER NORMAL IMPEDANCE AND R-WAVE MEASUREMENTS WERE OBSERVED. IT WAS NOTED THAT ALL LEAD PARAMETERS WERE STABLE AT IMPLANT AND WITHIN NORMAL LIMITS BEFORE AND AFTER IT WAS CONNECTED TO THE OTHER MANUFACTURER'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FLUOROSCOPIC IMAGING CONFIRMED THERE WAS NO LEAD DISLODGEMENT. THE DAY AFTER IMPLANT, THIS RV LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. IT WAS NOTED THAT DURING THE LEAD REVISION PROCEDURE, THE RV LEAD WAS TESTED WITH A PACING SYSTEM ANALYZER (PSA) AND, AGAIN, THERE WAS NORMAL SENSING AND PACE IMPEDANCE MEASUREMENTS WITH NO CAPTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221503 ↗
• MalfunctionJul 3, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS PATIENT OBSERVED A FLASHING RED CALL DOCTOR (RCD) ICON ON THEIR REMOTE MONITORING COMMUNICATOR. A FORCED CALL WAS COMPLETED ON THE COMMUNICATOR, DEVICE DATA WAS SUCCESSFULLY TRANSMITTED, AND THE FLASHING RCD VANISHED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR CLINIC. A SUBSEQUENT REVIEW OF THE REMOTE MONITORING DATA INDICATED THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN ALERT FOR A HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENT OF 2002 OHMS, WHICH TRIGGERED THE RCD ICON. THE RV PACE IMPEDANCE TREND GRAPH SHOWS AT LEAST ONE PREVIOUS HIGH OUT OF RANGE MEASUREMENT FOLLOWED BY A DECREASE INTO THE 1200 OHM RANGE, WHICH IS WITHIN NORMAL LIMITS, AND A RECENT GRADUAL INCREASE OVER APPROXIMATELY THE PAST TWO MONTHS. THE LEAD REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12113331 ↗
• InjuryJan 2, 2021Adverse 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 EXTRACTION DUE TO TWIDDLER'S SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; Twiddlers Syndrome

  MAUDE report 11104172 ↗
• InjuryNov 3, 2020Failure to Capture; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PRODUCT WAS EXPLANTED DUE BACTEREMIA. IT WAS ALSO NOTED THAT THIS LEAD EXHIBITED LOSS OF CAPTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection; No Code Available

  MAUDE report 10781229 ↗
• MalfunctionNov 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS AN ATTEMPTED LEAD DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT WHILE IMPLANTING THIS PASSIVE LEAD THE PHYSICIAN EXPERIENCED ECTOPY AND FELT THE COIL WAS CAUSING AN EXCESSIVE ECTOPY. THIS LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10768006 ↗
• InjuryOct 29, 2020High Capture Threshold; High Capture Threshold

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10756817 ↗
• MalfunctionJul 1, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS PATIENT WITH A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) A FEW MONTHS AGO AND RECENTLY NOTED THAT THE DEVICE WAS BEEPING. AFTER A FEW CONNECTIVITY ISSUES WITH THE REMOTE MONITORING SYSTEM THEY WERE ABLE TO GET THE DEVICE REPORT FOR REVIEW. REVIEW INDICATED THAT RIGHT VENTRICULAR (RV) LEAD HAD ALERTED DUE TO HIGH OUT OF RANGE IMPEDANCES GREATER THAN 2000 OHMS. THE GRAPH SHOWED THAT THE IMPEDANCES HAD A SHARP INCLINE TO CONTINUOUS HIGH OUT OF RANGE VALUES. THE LEAD REMAINS IN-SERVICE, AND NO FURTHER DETAILS WERE ABLE TO BE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10222051 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED AS PART OF A WHOLE SYSTEM EXPLANT DUE TO AN INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9546806 ↗
• InjuryNov 6, 2019Adverse 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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9287876 ↗

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,