ENDOTAK RELIANCE® G 0184Recalls & reported problems

Summary

The FDA's MAUDE database contains 838 adverse event reports that list this exact device (DI 00802526531187), received between Apr 9, 2013 and Mar 9, 2026 — classified as 7 deaths, 575 injuries, 256 malfunctions.

The most frequently reported specific device problem is “High impedance” (464 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 838 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN IN-RANGE SHOCK IMPEDANCE MEASUREMENT OF 116 OHMS. IT WAS NOTED THE SHOCK IMPEDANCE HAS BEEN GRADUALLY RISING AND THAT CALCIFICATION WAS SUSPECTED. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING THE UPPER LIMIT AND TO CONTINUE TO MONITOR. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545560 ↗
• InjuryOct 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE SUPERIOR VENA CAVA (SVC) COIL. DISTAL COIL TO CAN HAD AN IN-RANGE SHOCK IMPEDANCE MEASUREMENT OF 80 OHMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341215 ↗
• MalfunctionJul 31, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677407 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SHOCK IMPEDANCE OF THIS RIGHT VENTRICULAR (RV) LEAD MEASURED AT 115 OHMS, WHICH WAS WITHIN NORMAL LIMITS. HOWEVER, LATER, IT ROSE TO ABOVE 125 OHMS, WHICH WAS HIGH OUT OF RANGE. THIS WAS NOTED TO BE A GRADUAL RISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666129 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS UP TO 123 OHMS. NO OUT-OF-RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED. ALL EVIDENCE INDICATES THE RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION PROVIDED TO BOSTON SCIENTIFIC INDICATED THIS RV LEAD EVENTUALLY EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. NO CHANGES WERE MADE, AND THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666102 ↗
• MalfunctionJul 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK LEAD IMPEDANCE MEASUREMENTS MEASURING 124 OHMS. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609622 ↗
• InjuryJul 12, 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 A POCKET EROSION AND INFECTION. THE TECHNICAL SERVICE (TS) REFERRED THE PATIENT TO THE PHYSICIAN. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 22488210 ↗
• MalfunctionMay 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK LEAD IMPEDANCE MEASUREMENTS AND HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) NOTED THAT THIS WAS LIKELY ASSOCIATED WITH SPRING CONTACT AND CALCIFICATION. IT WAS ALSO NOTED THAT THERE WAS NO NOISE ON STORED EVENTS AND NO CHANGES TO THRESHOLD. TS RECOMMENDED PERFORMING A SHOCK VECTOR BREAKDOWN AND PROGRAMMING CHANGES. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089274 ↗
• InjuryMay 8, 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 POCKET EROSION AND INFECTION. REPORTEDLY, THE PATIENT LOST A LOT OF WEIGHT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 21990818 ↗
• MalfunctionApr 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 REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861062 ↗
• InjuryDec 10, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND ONE SHOCK DUE TO OVERSENSED NOISY SIGNALS. TECHNICAL SERVICES (TS) CONFIRMED THE NUMBER OF VENTRICULAR EPISODES HAS NEARLY DOUBLE OVER THE LAST WEEKS AND NOTED IMPEDANCES SPIKES WITHIN NORMAL LIMITS. ADDITIONALLY, THE R-WAVE AMPLITUDE HAS DECREASED. IN AN UPGRADE THERAPY PROCEDURE, THE PACE/SENSE PORTION OF THIS RV LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20899219 ↗
• InjuryNov 4, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603581 ↗
• MalfunctionAug 14, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS RIGHT VENTRICULAR LEAD DELIVERED ONE INAPPROPRIATE SHOCK DUE TO NOISE AND OVERSENSING. NO OTHER INFORMATION WAS PROVIDED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19982355 ↗
• InjuryJan 16, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. IT IS PLANNED TO CONTINUE TO MONITOR AND REPLACE THE LEAD DURING NEXT GENERATOR CHANGE OUT PROCEDURE. 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 18522623 ↗
• MalfunctionSep 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO BEING ACCIDENTALLY CUT DURING SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799075 ↗
• MalfunctionJul 28, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A RIGHT VENTRICULAR (RV) LEAD SHOWED A SUDDEN INCREASE IN SHOCK IMPEDANCES TO HIGH, OUT OF RANGE VALUES AND HAVE REMAINED THERE. THE SHOCK IMPEDANCES HAD BEEN STABLE, WITHIN NORMAL LIMITS BEFORE. NO NOISE ON THE PRESENTING ELECTROGRAM, ALSO, NO STORED EVENTS. VARIOUS FOLLOW UP RECOMMENDATIONS WERE GIVEN FOR THE PATIENT. THE CRT-D AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE MENTIONED THAT THE RV COIL WAS REPROGRAMMED TO ANOTHER VECTOR AT AN OFFICE VISIT. NORMAL SHOCK IMPEDANCES WERE OBSERVED AFTER THE REPROGRAMMING. NO NOISE OR CHANGES WERE REPRODUCED WITH MOVEMENT OR MANIPULATION. THE CRT-D AND THE RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411294 ↗
• MalfunctionJul 18, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT-OF-RANGE (OOR) RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS MEASURING, GREATER THAN 3,000 OHMS. TECHNICAL SERVICES (TS) NOTED THERE WAS ONLY ONE VALUE THAT WAS OOR. TS DISCUSSED POSSIBLE CAUSES AND PROVIDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344348 ↗
• InjuryMay 30, 2023Signal Artifact/Noise; Failure to Capture; Fracture; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Fracture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO FAILURE TO CAPTURE AT MAX OUTPUT AND NOISE ON THE RV CHANNEL RESULTING FROM A FRACTURE. THE PHYSICIAN DECIDED TO DOWNGRADE THE PATIENT TO A DUAL CHAMBER PACEMAKER WITH THE LEFT VENTRICULAR (LV) LEAD PLUGGED INTO RV PORT AND PROGRAMMED UNIPOLAR. PATIENT IS NOT PACEMAKER DEPENDENT. TECHNICAL SERVICES DISCUSSED REPROGRAMMING OPTIONS FOR RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025284 ↗
• MalfunctionMay 30, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE PACING IMPEDANCE MEASUREMENTS WHICH WERE NOT OUT OF RANGE. THE LEAD WAS TESTED WHICH DID NOT ELICIT ANY IMPEDANCE CHANGES. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS WITH THE REP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED MENTIONING THAT AN ALERT FOR NON-PHYSIOLOGIC RV LEAD NOISE WAS TRIGGERED. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017752 ↗
• InjuryMay 22, 2023No Apparent Adverse Event; High Capture Threshold; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO UNKNOWN REASONS. 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 16980846 ↗
• MalfunctionMay 22, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND OVERSENSING. FURTHER EVALUATION AND REPROGRAMING OF THE DEVICE WERE DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED DETAILING THAT THE DEVICE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO THE OVERSENSING. FURTHERMORE, PACING INHIBITION OF LESS THAN TWO SECONDS AND LOW WITHIN RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. FURTHER MONITORING OF THE PATIENT WAS DISCUSSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976541 ↗
• InjuryMay 16, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING AND SHOCKING IMPEDANCE OUT OF RANGE. 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 16940921 ↗
• MalfunctionMay 10, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK LEAD IMPEDANCE VALUES THAT WERE GREATER THAN 200 OHMS, WHICH WAS OUT-OF-RANGE, IN THE TRIAD CONFIGURATION. IT WAS NOTED THAT REPROGRAMMING AT IN-PERSON INTERROGATION TO THE COIL TO CAN VECTOR CONFIGURATION RESOLVED THE OUT-OF-RANGE IMPEDANCE. PHYSICIAN WILL FOLLOW-UP WITH PATIENT IN THE FUTURE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902594 ↗
• MalfunctionMay 9, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE. BOSTON SCIENTIFIC REPRESENTATIVE HAD CONCERNED ABOUT THE 21HR DAILY LEAD MEASUREMENT AND 24HR DEVICE CLOCK MEASUREMENTS, AS NO OUT OF RANGE MEASUREMENTS WERE NOTED. IT IS RECOMMENDED TO HAVE PATIENT PERFORM PATIENT INITIATIVE INTERROGATION (PII). THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OUT OF RANGE SHOCK IMPEDANCE WAS GREATER THAN 200 OHMS. THERE WAS AN INCREASE IN FROM 40-50 OHMS. THE LEAD WAS DUAL COILED AND PROGRAMMED TRAID. PATIENT WILL BE BROUGHT IN THE CLINIC TO PERFORM ADDITIONAL TESTING. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900087 ↗
• InjuryMay 8, 2023High impedance; High impedance

  IT WAS REPORTED THAT WHILE THE DEVICE WAS BEING EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION, THE PHYSICIAN ELECTED TO SURGICALLY ABANDON AND REPLACE THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF 150 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892602 ↗

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,