ENDOTAK RELIANCE® G 0174Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00802526373640), received between Oct 12, 2016 and Sep 29, 2026 — classified as 66 injuries, 46 malfunctions.

The most frequently reported specific device problem is “High impedance” (73 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Jul 24, 2025Class IOpen, Classified

   Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

   Z-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements. Technical Services (TS) was consulted and confirmed out of range measurements. TS noted that the system was reprogramming to a different vector with measurements that were within range. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933493 ↗
• InjuryJul 20, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE PROCEDURE, THIS RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. THE PHYSICIAN OPTED TO SURGICALLY ABANDON BOTH LEADS. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882040 ↗
• InjuryJul 15, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH SHOCK IMPEDANCE VALUES. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REMOVE THE LEAD AND IMPLANT A NEW DEVICE WITH LEADS SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD EXHIBITED AREAS OF CALCIFICATION THAT WERE OBSERVED DURING THE REVISION PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25829108 ↗
• MalfunctionJul 10, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING THAT LED TO PACING INHIBITION, INCLUDING MULTIPLE EPISODES WITH PAUSES GREATER THAN TWO SECONDS IN A PACING DEPENDENT PATIENT. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND SHOWED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES, CONSISTENT WITH THE REPORTED PACING INHIBITION. THE PATIENT WAS EVALUATED, AND TS DISCUSSED TROUBLESHOOTING OPTIONS. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 25787045 ↗
• MalfunctionMay 13, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED AN ABRUPT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT EXPERIENCED A FALL, WHICH TECHNICAL SERVICES (TS) SUSPECTED CAUSED DAMAGE TO THE SYSTEM. AN EVALUATION WAS PERFORMED WITH VECTOR BREAKDOWNS AND ISOMETRICS, AND ALL MEASUREMENTS WERE WITHIN RANGE. TS RECOMMENDED PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164107 ↗
• MalfunctionMay 5, 2026High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THE DEVICE DATA DUE TO CONCERNS OF INCREASE IN RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCES. UPON REVIEW OF THE DAILY THRESHOLD AND IMPEDANCE MEASUREMENTS TRENDS, THE RV LEAD EXHIBITED OUT OF RANGE INTRINSIC AMPLITUDE MEASUREMENTS AND A GRADUAL RISE IN THE SHOCK LEAD IMPEDANCES FROM ABOUT 50 OHMS TO 108 OHMS SINCE 2018. IT WAS NOTED THE SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS (WNL). TS RECOMMENDED FOR CONTINUED MONITORING. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089098 ↗
• InjuryFeb 19, 2026Use of Device Problem; Low impedance; Connection Problem

  IT WAS REPORTED THAT INTERROGATION OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS UNSUCCESSFUL, AND THIS CRT-D HAD REACHED THE EXPLANT INDICATOR IN (b)(6) 2024. REVIEW OF DEVICE SETTINGS NOTED LOW OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS FOR MORE THAN A YEAR ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH WAS PURPOSEFULLY CONNECTED TO THE LEFT VENTRICULAR (LV) PORT AT THE LAST DEVICE REPLACEMENT PROCEDURE. THIS CRT-D AND RV LEAD REMAIN IMPLANTED, HOWEVER BATTERY REPLACEMENT WAS ANTICIPATED. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RV LEAD IMPEDANCE ISSUE WAS KNOWN AT THE PREVIOUS DEVICE CHANGEOUT, AND THE RV AND LV LEADS WERE PURPOSEFULLY SWITCHED IN THE HEADER DURING THE BATTERY REPLACEMENT PROCEDURE FOR THIS REASON. AT THIS TIME, THERE ARE NO OTHER PLANS FOR ADDITIONAL INTERVENTION, OTHER THAN THE UPCOMING BATTERY REPLACEMENT. THIS RV LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386306 ↗
• MalfunctionJan 15, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY RISING HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) RECOMMENDED MONITORING AND REPLACING IF THE LEAD GETS TOO HIGH OUT OF RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089902 ↗
• InjuryDec 8, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. THE LEAD EXHIBITED PACING IMPEDANCE GRADUALLY INCREASING, AS WELL AS, PACING THRESHOLDS WHICH ALSO GRADUALLY INCREASED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750897 ↗
• MalfunctionNov 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF 200 OHMS DURING A PRE-SURGERY CHECK AND A CLINIC VISIT. IT WAS NOTED THAT THE AVERAGE DAILY MEASUREMENTS FOR THIS RV LEAD WERE IN RANGE. THE FIELD REPRESENTATIVE STATED THAT ONLY THE RV TO CAN WAS IN RANGE, SO REPROGRAMMING TO THE RV TO CAN WAS COMPLETED. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467111 ↗
• InjuryOct 31, 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 INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23433723 ↗
• InjuryOct 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCE HIGH OUT OF RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411497 ↗
• InjuryOct 28, 2025High impedance; Nonstandard Device; High impedance; Nonstandard Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED SUDDEN OUT OF RANGE MEASUREMENTS AND NORMAL SENSING. TS DISCUSSED POSSIBLE CONDUCTOR FRACTURE AND RECOMMENDED PERFORMING A VECTOR BREAKDOWN AND DISCUSS POSSIBLE REPROGRAMMING OPTIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405751 ↗
• MalfunctionSep 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. THIS WAS SUSPECTED AS ASSOCIATED WITH A PROXIMAL COIL ISSUE. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979625 ↗
• MalfunctionJul 30, 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 22667953 ↗
• InjuryJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE AS STATED PREVIOUSLY. A NEW RV LEAD WAS IMPLANTED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666168 ↗
• MalfunctionJul 30, 2025High impedance; Connection Problem; High impedance; Connection Problem

  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 22665639 ↗
• MalfunctionJul 30, 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 22664810 ↗
• MalfunctionJul 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. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649240 ↗
• MalfunctionJul 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649212 ↗
• MalfunctionJul 28, 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 22637828 ↗
• MalfunctionJul 28, 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 22633681 ↗
• InjuryJul 10, 2025High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REFERRED THIS PATIENT TO THE CLINIC. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fever; No Clinical Signs, Symptoms or Conditions; Sepsis

  MAUDE report 22473677 ↗
• MalfunctionMay 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH THIS RIGHT VENTRICULAR (RV) LEAD RECORDED A CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY DUE TO A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. FURTHER TESTING AND REPROGRAMMING OPTIONS WERE RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071608 ↗
• 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 21859083 ↗

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-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