ENDOTAK RELIANCE® G 0186Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00802526531200), received between Oct 22, 2018 and Oct 1, 2024 — classified as 1 death, 21 injuries, 18 malfunctions.

The most frequently reported specific device problem is “High impedance” (23 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH CAPTURE THRESHOLD AND LOW IMPEDANCE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20341597 ↗
• MalfunctionApr 10, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 200 OHMS. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707292 ↗
• MalfunctionMar 31, 2023Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, THE PATIENT EXPERIENCED A SYNCOPAL EVENT AND WAS EVALUATED IN A HOSPITAL SETTING. UPON REVIEW, NO STORED EPISODES WERE FOUND ON THE DEVICE. FURTHER TESTING WAS RECOMMENDED REGARDING THIS LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE OUT OF RANGE MEASUREMENTS COULD NOT BE DETERMINED BUT A LEAD DAMAGE WAS SUSPECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Syncope/Fainting

  MAUDE report 16659481 ↗
• 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16482130 ↗
• InjuryFeb 17, 2023High impedance; High impedance

  IT WAS REPORTED THAT, OVER THE LAST YEAR, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING PACING IMPEDANCE MEASUREMENTS AND HIGH OUT-OF-RANGE SHOCK IMPEDANCES. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND 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 16397433 ↗
• InjuryFeb 9, 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 16342219 ↗
• InjuryNov 22, 2022High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A RIGHT VENTRICULAR (RV) LEAD DELIVERED SHOCK THERAPY THAT DID NOT CONVERT THE RHYTHM THE PATIENT WAS EXPERIENCING. THE SHOCK IMPEDANCE STARTED WITHIN RANGE BUT AT SOME POINT, POLARITY WAS REVERSED, AND THE IMPEDANCE WAS HIGH, OUT OF RANGE. AN OPEN CIRCUIT ALERT WAS TRIGGERED. THERAPY WAS EXHAUSTED AND THE PATIENT REQUIRED EXTERNAL THERAPY. THE PATIENT IS UNDER CONTROL NOW. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND IS BEING MONITORED. THE SYSTEM WAS REPROGRAMMED BUT ADDITIONAL TESTING AND REPROGRAMING FOLLOW UP WAS SUGGESTED. THE CRT-D AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842389 ↗
• InjurySep 2, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO NOISE. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349520 ↗
• MalfunctionJun 15, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS PHYSICIAN NOTED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS (>200 OHMS) IN MULTIPLE SENSING CONFIGURATIONS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED PERFORMING IN-CLINIC PROVOCATIVE MANEUVERS TO ASSESS THE RIGHT VENTRICULAR (RV) LEAD INTEGRITY. ADDITIONALLY, IF THE PATIENT HAS NOT RECEIVED ANY RECENT SHOCKS, IT WAS RECOMMENDED TO PERFORM A COMMANDED SHOCK TEST TO VERIFY THE ACTUAL DELIVERED SHOCK IMPEDANCE MEASUREMENT. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691867 ↗
• MalfunctionJun 8, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATOR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 200 OHMS, IN ALL VECTORS, ONE DAY POST IMPLANT. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639899 ↗
• InjuryJun 7, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS BEEN SHOWING HIGH, OUT OF RANGE SHOCK IMPEDANCES THAT HAVE BEEN INCREASING OVER TIME. MORE ANALYSIS WAS RECOMMENDED BUT THE RV LEAD REMAINS IN SERVICE AT THIS POINT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628230 ↗
• MalfunctionMay 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ONE OF PATIENT'S LEAD CAME OFF AND WAS PROGRAMMED OFF AS THE LEAD WAS CAUSING THE BATTERY OF THE DEVICE TO DRAIN. NO FURTHER INFORMATION PROVIDED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522524 ↗
• MalfunctionMar 7, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING A SCHEDULED DEVICE REPLACEMENT SURGICAL PROCEDURE, THE EXISTING DUAL COIL RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE BUT EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. THE DEVICE WAS NOTED TO BE IN THE POCKET WHEN PERFORMING THE MEASUREMENTS. SURROUNDING EQUIPMENT WAS TURNED OFF TO RULE OUT ANY ELECTROMAGNETIC INTERFERENCE (EMI). THE RV LEAD WAS RECONNECTED IN THE DEVICE HEADER PORT TWO TIMES. THE PHYSICIAN NOTED THAT THE LEAD TERMINAL WAS TIGHT IN THE DEVICE HEADER PORT, BUT THE LEAD TERMINAL PIN WAS VISUALLY CONFIRMED TO BE PAST THE CONNECTOR BLOCK IN THE HEADER, AND THE HEADER SET SCREWS WERE SECURE. CONTINUING TO TROUBLESHOOT, THE PHYSICIAN THEN SWITCHED THE HIGH VOLTAGE RV LEAD TERMINAL PINS IN THE OPPOSITE DEVICE HEADER PORTS. A VECTOR BREAKDOWN WAS PERFORMED IN BOTH CONFIGURATIONS AND A SHOCK IMPEDANCE MEASUREMENT OF 45 OHMS WAS OBSERVED IN THE RV LEAD DISTAL COIL TO DEVICE CAN VECTOR. THIS MEASUREMENT IS WITHIN NORMAL SPECIFICATION LIMITS. A SECOND NEW ICD DEVICE OF THE SAME MODEL WAS ATTEMPTED BUT WITH THE SAME HIGH OUT OF RANGE SHOCK IMPEDANCE RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684635 ↗
• MalfunctionJan 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD MAY HAVE DISLODGED DUE TO AN ODD LOOKING MORPHOLOGY ON SHOCK CHANNEL ASSOCIATED WITH SOME ATRIAL PACING INTERVALS. SOME SENSING AND MORPHOLOGY IN ALIGNMENT SO NOT HAPPENING CONSISTENTLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13138002 ↗
• MalfunctionOct 28, 2021High impedance; High impedance

  IT WAS REPORTED THAT GRADUALLY OVER THE PAST FOUR YEARS, THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED INCREASED, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS (UP TO 143 OHMS). NO EVIDENCE OF NOISY SIGNALS NOR OTHER SENSING ISSUES WAS PRESENT. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED AND IT WAS DISCUSSED THAT THE INCREASED SHOCK IMPEDANCE WAS LIKELY THE RESULT OF PATIENT FACTORS, SUCH AS CALCIFICATION OR MINERALIZATION. IT WAS RECOMMENDED TO INCREASE THE DEVICE'S SHOCK ALERT VALUE AND CONTINUE WITH REMOTE MONITORING. THE PHYSICIAN SUBSEQUENTLY INCREASED THE SHOCK ALERT LIMIT AND IS CONTINUING WITH NORMAL FOLLOW-UPS. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713642 ↗
• MalfunctionOct 15, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT, MEASURING GREATER THAN 2000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED THE AVAILABLE LATITUDE DATA AND CONFIRMED THE PRESENTING EGM SIGNALS WERE CLEAN AND ARTEFACT FREE. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED ADDITIONAL TESTING, SUCH AS PERFORMING ISOMETRICS AND PROVOCATIVE MANEUVERS TO CONFIRM NO NOISE IS PRESENT. THE PLAN IS TO CONTINUE MONITORING THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642742 ↗
• MalfunctionSep 22, 2021High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATOR LEAD EXHIBITED PACE IMPEDANCE MEASUREMENTS HIGH OUT-OF-RANGE GREATER THAN 2,000 OHMS. IT WAS ALSO NOTED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED AT TIME OF IMPLANT AND SHOCK IMPEDANCE MEASURED LOW WITHIN NORMAL RANGE AT 30 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514610 ↗
• InjuryJul 23, 2021Signal Artifact/Noise; Defective Device; Impedance Problem; Signal Artifact/Noise; Defective Device; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE IMPEDANCES AND NOISE. SUBSEQUENTLY, THE RV LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR LEAD. IT WAS SUSPECTED THAT THERE WAS SOME DAMAGE TO THE LEAD, POSSIBLE INSULATION BREACH, MOST LIKELY DUE TO THE FRICTION CAUSED BY THE LEAD RUBBING AGAINST THE GENERATOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221667 ↗
• InjuryApr 28, 2021Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO OBSERVATIONS OF AN INSULATION BREACH, NOISE, OVERSENSING WITH NO PACING INHIBITION OBSERVED AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741935 ↗
• MalfunctionFeb 20, 2021Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 2000 OHMS. IN ADDITION, THERE WAS NOISE OBSERVED ON THE RIGHT VENTRICULAR (RV) SHOCK CHANNEL. THE PLAN IS TO CONTINUE TO MONITOR AT THIS TIME. THE DEVICE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11356153 ↗
• DeathFeb 10, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT DURING A COMPETITOR NORMAL DEVICE CHANGE OUT AND UPGRADE PROCEDURE, THE PHYSICIAN ELECTED TO REPLACE THIS BOSTON SCIENTIFIC LEAD DUE TO RISING THRESHOLDS AND PACING IMPEDANCE MEASUREMENTS HOWEVER, NO VALUES WERE REPORTED OUT OF RANGE AT THE TIME OF THE PROCEDURE. DURING THIS SURGICAL UNDERTAKING, THE PHYSICIAN ENCOUNTERED SUPERIOR VENA CAVA (SVC) ADHESIONS WHICH RUPTURED DURING THE EXTRACTION PORTION OF THE PROCEDURE. ADDITIONAL SURGICAL INTERVENTION WAS IMMEDIATELY PERFORMED DUE TO TAMPONADE INDUCED BLOOD LOSS. THE PATIENT PASSED AWAY AS A RESULT OF THE PROCEDURE. THE LEAD WAS EXTRACTED IN FRAGMENTS AND RETURNED FOR ANALYSIS.

  Patient problems: Cardiac Tamponade

  MAUDE report 11307337 ↗
• MalfunctionJan 25, 2021High impedance; High impedance

  IT WAS REPORTED THE PATIENT IMPLANTED WITH THIS DEFIBRILLATION LEAD EXPIRED. THERE WERE NO ALLEGATIONS AGAINST LEAD FUNCTIONALITY. REVIEW OF STORED DATA FOUND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS HAD BEEN OBSERVED. THE HIGH MEASUREMENTS WERE INTERMITTENT AND THERE WAS NO EVIDENCE OF NOISE ON THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED RELATED TO THE OUT OF RANGE IMPEDANCE MEASUREMENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11227935 ↗
• InjuryJan 18, 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 REVISION DUE TO POCKET EROSION AND INFECTION. IN ADDITION, THE PATIENT NOW HAS A LEADLESS NON-BOSTON SCIENTIFIC PACEMAKER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: No Code Available; Pocket Erosion; Unspecified Infection

  MAUDE report 11191059 ↗
• MalfunctionJan 15, 2021High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED STABLE, BUT HIGH AND OUT-OF-RANGE, SHOCK IMPEDANCE MEASUREMENTS. IMPEDANCE WAS OUT OF RANGE IN ALL THREE VECTORS. A BOSTON SCIENTIFIC TECHNICAL SERVICES REPRESENTATIVE DISCUSSED TROUBLESHOOTING MEASURES BUT NONE HAVE BEEN REPORTED. NO ADVERSE PATIENT EFFECT WERE REPORTED. THE LEAD REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11181973 ↗
• MalfunctionDec 18, 2020High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED LOW WITHIN RANGE SHOCK IMPEDANCE MEASUREMENTS DURING DAILY MEASUREMENTS, AS WELL AS SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11042376 ↗

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,