ENDOTAK RELIANCE® SG 0182Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00802526531163), received between May 6, 2019 and Jul 29, 2025 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649183 ↗
• InjuryNov 15, 2023High impedance; High impedance

  IT WAS REPORTED THAT, DURING THE EXPLANT PROCEDURE OF THE OLD DEVICE DUE TO NORMAL BATTERY DEPLETION (NBD), THIS RIGHT VENTRICULAR (RV) LEAD WAS PLUGGED INTO THE NEW DEVICE AND EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE. THE TECHNICAL SERVICES (TS) INDICATED TO THE FIELD REPRESENTATIVE TO UNPLUG ALL ELECTROMAGNETIC INTERFERENCE (EMI) SOURCES, BUT THE MEASUREMENTS WERE STILL OUT OF RANGE. SUBSEQUENTLY, 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 18144731 ↗
• InjuryDec 20, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS, GREATER THAN 125 OHMS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS RV LEAD WAS SURGICALLY CAPPED/ABANDONED AND REPLACED WITH A NEW LEAD. IT WAS NOTED THAT THE DEVICE POCKET WAS ALSO REVISED. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048414 ↗
• MalfunctionOct 17, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR STARTED EMITTING BEEPING TONES. TECHNICAL SERVICES (TS) REVIEWED THIS DEVICE DATA AND NOTICED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCE OF 125 OHMS. THE BEEPING WAS CONFIRMED TO HAVE BEEN TRIGGERED BY THE IMPEDANCE MEASUREMENT. THE SHOCK IMPEDANCE TRENDING APPEARS TO BE SLIGHTLY ELEVATED OVER THE LAST YEAR. AS 125 OHMS IS NOT INDICATIVE OF A LEAD FRACTURE, TS RECOMMENDED TO BRING THE PATIENT INTO CLINIC TO TURN BEEPING OFF, EVALUATE THE SHOCK LEAD, INCREASE THE OOR ALERT TO 150 OHMS AND CONTINUE MONITORING THE PATIENT. IF IMPEDANCE EXCEEDS 150 OHMS A COMMANDED SHOCK SHOULD BE CONSIDERED. FURTHER INFORMATION WAS RECEIVED INDICATING THAT NO COMMANDED SHOCKS WERE PERFORMED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THIS LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644221 ↗
• InjuryJul 23, 2021Signal Artifact/Noise; High impedance; Defective Device; Signal Artifact/Noise; High impedance; Defective Device

  IT WAS REPORTED THAT THIS LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE DATA AND A POSSIBLE LEAD DAMAGE IS SUSPECTED TO BE THE CAUSE OF THE IMPEDANCE ISSUES AND THE NOISY SIGNALS. TROUBLESHOOTING WAS RECOMMENDED BY TS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION CONFIRMED THIS PATIENT WILL HAVE A HIGH-ENERGY SHOCK TESTING SCHEDULE. PHYSICIAN IS AWARE OF THE RECOMMENDATION FROM TS.

  Patient problems: Insufficient Information

  MAUDE report 12221277 ↗
• MalfunctionJan 2, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND RIGHT VENTRICULAR (RV) LEAD, EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE OF 127 OHMS. THE PHYSICIAN ADVISED THEY BELIEVE IT MAY BE DUE TO A RECENT MEDICATION CHANGE. A TECHNICAL SERVICE (T/S) CONSULTANT REVIEWED THE DATA FROM THE HOME MONITOR, NOTING A GRADUAL INCREASE OF OUT OF RANGE SHOCK IMPEDANCE SINCE (B)(6) 2020 OF 104 OHMS TO 127 OHMS. T/S RECOMMENDED LEAD INTEGRITY TESTING , BUT ADVISED MAY BE DUE TO PATIENT CONDITION. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11104633 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11040322 ↗
• MalfunctionJul 6, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD A GRADUAL RISE IN SHOCK IMPEDANCE, AND WERE NOW OUT OF RANGE GREATER THAN 125 OHMS. THE PLAN APPEARED TO BE TO CONTINUE TO MONITOR AT THIS TIME, AND APPEARED THAT THEY WOULD CONSIDER INCREASING THE ALERT LIMIT TO 150 OHMS. THE LEAD REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237012 ↗
• InjuryApr 30, 2020Signal Artifact/Noise; Failure to Capture; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Low impedance; Signal Artifact/Noise; Failure to Capture; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED OVERSENSED NOISE RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE SHOCKS. IT WAS ALSO NOTED THAT THE IMPEDANCE AND SENSING MEASUREMENTS HAD DECREASED. THERE WAS A CONCERN THE LEAD HAD FRACTURED. TACHY THERAPY WAS PROGRAMMED OFF AND THE PATIENT WAS PLACED ON AN EXTERNAL DEFIBRILLATOR PRIOR TO A REVISION PROCEDURE. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10013526 ↗
• InjuryJan 21, 2020High impedance; Device Sensing Problem; High Capture Threshold; High impedance; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS, NOISE AND VARIABILITY IN PACING IMPEDANCE MEASUREMENTS. THE LEAD WAS EXPLANTED DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9612078 ↗
• MalfunctionJun 19, 2019High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCES. ONE MEASUREMENT WAS OBSERVED TO BE HIGH AND OUT OF RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND MONITORING THE SYSTEM WAS RECOMMENDED. THE PHYSICIAN AGREED WITH THE PLAN TO CONTINUE MONITORING. THE ICD AND THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8712516 ↗
• InjuryMay 6, 2019High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN SHOCK IMPEDANCE MEASUREMENTS. SURGICAL INTERVENTION WAS PERFORMED AND THE RV LEAD WAS CUT AND ABANDONED IN THE PATIENT. THE END OF THE RV LEAD WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581428 ↗
• MalfunctionMay 6, 2019High impedance; High impedance

  IT WAS REPORTED THAT, DURING A ROUTINE FOLLOW-UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) CHANNEL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND TROUBLESHOOTING RECOMMENDATIONS WERE PROVIDED. THE RECOMMENDED TESTING WAS PERFORMED IN CLINIC. IT WAS NOTED THAT THE SHOCK IMPEDANCE REMAINED HIGH BUT NO OTHER ABNORMAL ELECTRICAL MEASUREMENTS WERE OBSERVED. THE PHYSICIAN HAS ELECTED TO CONTINUE MONITORING THE SYSTEM. THIS ICD AND THE RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581391 ↗

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-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,
• 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