ENDOTAK RELIANCE® G 0296Recalls & reported problems

Summary

The FDA's MAUDE database contains 862 adverse event reports that list this exact device (DI 00802526531279), received between Apr 21, 2016 and Sep 18, 2026 — classified as 4 deaths, 625 injuries, 233 malfunctions.

The most frequently reported specific device problem is “High impedance” (268 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-2326-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 862 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026High impedance; Failure to Convert Rhythm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829979 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829439 ↗
• InjurySep 15, 2026Adverse 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 was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50774396 ↗
• MalfunctionSep 9, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements due to a system Code 1005. Technical Services (TS) was consulted and recommended clearing the Code 1005 and further evaluating the system. TS noted that a shock was appropriately delivered to the patient. TS recommended considering lead replacement due to the system Code. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688599 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602192 ↗
• MalfunctionAug 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421674 ↗
• MalfunctionJul 29, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited a high out of range shock impedance measurement. Technical Services (TS) was consulted and confirmed that aside from the singular out of range measurement, impedance measurements remained stable. TS confirmed no lead noise and recommended further evaluation in clinic. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50076502 ↗
• MalfunctionJul 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058100 ↗
• InjuryJul 21, 2026Failure to Capture; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD DROPPING IMPEDANCE MEASUREMENTS THAT REMAINED WITHIN NORMAL LIMITS ALONG WITH HIGH CAPTURE THRESHOLDS. THERE WAS INTERMITTENT CAPTURE FOR THE RV LEAD AS WELL AS THE LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND DISCUSSED BOTH VENTRICULAR LEADS SHOWED LOSS OF CAPTURE (LOC). LATER IT WAS NOTED THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED LOC. THE PATIENT WAS BROUGHT IN FOR A LEAD REVISION, AND THE RA LEAD WAS ATTEMPTED BUT UNABLE TO GET ACCEPTABLE PARAMETERS LIKELY DUE TO PATIENT TISSUE. THE PHYSICIAN INSTEAD DECIDED TO PERFORM A GENERATOR CHANGEOUT TO MAXIMIZE LONGEVITY FOR THE LEADS, SO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. THE PHYSICIAN ALSO DISCUSSED FUTURE OPTIONS FOR DEVICE PLACEMENT WITH THE PATIENT. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25897188 ↗
• InjuryJul 10, 2026Adverse 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 25786538 ↗
• InjuryJun 23, 2026Adverse 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25595723 ↗
• MalfunctionMay 4, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED AN ABRUPT INCREASE FROM NORMAL TO HIGH, OUT OF RANGE SHOCK IMPEDANCE VALUES, FOR WHICH AN ALERT WAS TRIGGERED. A VECTOR BREAKDOWN WAS COMPLETED AND THE OUT OF RANGE BEHAVIOR WAS CONFIRMED. THERE WAS NO NOISE NOR SYMPTOMS REPORTED. A COMMANDED SHOCK WAS COMPLETED AT CLINIC AND DEVICE WAS REPROGRAMMED TO RIGHT VENTRICLE TO CAN WITH HIGHEST OUTPUT FOR ALL SHOCKS AND INITIAL POLARITY. THE RV LEAD REMAINS IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 25071312 ↗
• InjuryApr 29, 2026Adverse 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 25032063 ↗
• MalfunctionApr 27, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS ABOVE 200 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON CASE REVIEW SUGGESTED THIS TO BE A POSSIBLE PROXIMAL COIL ISSUE. ADDITIONALLY, TS MENTIONED THAT THE IMPEDANCE MEASUREMENTS HAVE BEEN STABLE FOR THIS RV LEAD, WITH EXCEPTION OF A PREVIOUSLY RECORDED FLUCTUATION OF ABOUT 30 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TS RECOMMENDED REPROGRAMMING OPTIONS FOR THIS PATIENT. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002428 ↗
• MalfunctionApr 24, 2026High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT LOW R-WAVE AMPLITUDES WERE OBSERVED ON THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THERE WAS NO EVIDENCE OF UNDERSENSING. REVIEW OF SHOCK IMPEDANCE TRENDS SHOWED A GRADUAL RISE IN MEASUREMENTS FROM 50 OHMS AT IMPLANT TO A RECENT AVERAGE OF 70 OHMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THE DEVICE WAS PROGRAMMED TO INITIAL POLARITY, AND PROGRAMMING TO MAXIMUM ENERGY SHOCKS WAS ADVISED. IT WAS NOTED THAT THERE WAS APPROXIMATELY 1.5 YEARS REMAINING ON THE BATTERY, AND THE PHYSICIAN MAY WISH TO RE-EVALUATE THE LEAD AT BATTERY REPLACEMENT TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT R-WAVE AMPLITUDE WAS 10 MV AND SHOCK IMPEDANCE WAS STABLE AT 69 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988115 ↗
• InjuryApr 23, 2026Adverse 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 ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 24968970 ↗
• MalfunctionApr 16, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES. TECHNICAL SERVICES (TS) WAS CONSULTED FOR PROGRAMMING ASSISTANCE. TS PROVIDED POSSIBLE PROGRAMMING RECOMMENDATIONS. 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 24901374 ↗
• InjuryApr 15, 2026High impedance; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES OF VALUES GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED REPROGRAMMING GUIDANCE. AFTER REPROGRAMMING, A TREND OF LOW WITHIN RANGE SHOCK IMPEDANCES WERE OBSERVED. FURTHER EVALUATION WAS RECOMMENDED. SUBSEQUENTLY, THIS RV LEAD WAS REPORTED TO BE SURGICALLY ABANDONED, AND A NEW LEAD WAS IMPLANTED. OTHER THAN THE INTERVENTION NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886939 ↗
• MalfunctionApr 9, 2026Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE SIGNALS ON BOTH RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD WITH ONE SIGNAL BEING OVERSENSED. THERE WAS NO PACING INHIBITION OR ASYSTOLE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835509 ↗
• InjuryApr 8, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN ADVISORY. THIS RV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824422 ↗
• MalfunctionApr 7, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING FOR THIS DEVICE. THE RV LEAD AND ICD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811393 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24647232 ↗
• InjuryMar 15, 2026Material Integrity Problem

  IT WAS REPORTED BY THE FIELD CLINICAL REPRESENTATIVE THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INSULATION BREACH. AS A RESULT, THIS RV LEAD WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602064 ↗
• MalfunctionMar 13, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED SHOCK IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED ASSISTANCE. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589395 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO BACTEREMIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS ABANDONED.

  Patient problems: Bacterial Infection

  MAUDE report 24501050 ↗

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,