ENDOTAK RELIANCE® S 640273-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 00802526601811), received between Jun 18, 2019 and Sep 29, 2026 — classified as 2 deaths, 303 injuries, 86 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (54 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 391 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited an unknown product performance anomaly. A revision procedure was performed. This RV lead was surgically abandoned and replaced with a new lead successfully. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927562 ↗
• InjurySep 28, 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 50919653 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was surgically abandoned due to unknown reasons. This RV lead was successfully replaced and no additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789024 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736139 ↗
• InjuryJul 28, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements. Technical Services (TS) was consulted as the lead was scheduled for replacement but for an unknown reason. TS reviewed the lead and determined there were multiple red alerts for out of range spikes with daily variability in testing. TS noted that the lead was stable since implant in impedance measurements and only noted a few spikes. Subsequently, the lead was explanted, and a new lead was successfully implanted. No additional adverse patient effects were reported. This RV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060477 ↗
• InjuryJul 20, 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 25883619 ↗
• InjuryMay 29, 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 25327494 ↗
• InjuryMar 12, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. THIS RV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS EXPLANTED DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AS THIS LEAD WAS DAMAGED DURING THE EXTRACTION, IT IS NOT EXPECTED TO RETURN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24585991 ↗
• InjuryMar 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24565031 ↗
• InjuryMar 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD POKED HOLE IN THE TRICUSPID AREA. THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RV LEAD EXHIBITED NO PERFORATION. THE PATIENT HAD MILD SYMPTOMS. THIS RV LEAD WAS KEPT BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552626 ↗
• InjuryMar 3, 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 24494015 ↗
• InjuryFeb 20, 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24405051 ↗
• InjuryFeb 17, 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. THIS RV LEAD WAS EXPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD BLOOD INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24364628 ↗
• MalfunctionFeb 11, 2026Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD A DECREASE ON ITS PACING PERCENTAGE, SO A REVIEW WAS REQUESTED. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED STORED DATA. TS DISCUSSED HOW PREMATURE VENTRICULAR CONTRACTIONS (PVC) RIGHT AFTER ATRIAL PACING WERE SUSPECTED. THIS RESULTED IN THE PATIENTS RIGHT VENTRICULAR SIGNALS BEEN BLANKED AND PACING BEEN DELIVERED DURING THE RIGHT VENTRICLE REFRACTORY PERIOD. LOSS OF CAPTURE (LOC) WAS SUSPECTED FOR THE RV BASED ON AVAILABLE INFORMATION. TS DISCUSSED PROGRAMMING OPTIONS FOR THIS DEVICE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314524 ↗
• InjuryFeb 5, 2026Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED RECENTLY WHICH WAS WHEN THE UNDERSENSING WAS NOTED. SENSITIVITY WAS INITIALLY INCREASED BUT DID NOT IMPROVE SENSING. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NON-BOSTON SCIENTIFIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD FOR BIPOLAR SENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD IS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272450 ↗
• InjuryJan 28, 2026Device Sensing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SENSING ISSUE. DEVICE DATA REVIEW DETERMINED THERE WAS SEVERAL SHOCK AND ROUND OF ANTI-TACHYCARDIA PACING (ATP) DELIVERED. ALL DELIVERED WAS CONFIRMED TO BE APPROPRIATE. THIS LEAD WAS SUBSEQUENTLY DEACTIVATED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200895 ↗
• InjuryJan 26, 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24179470 ↗
• MalfunctionJan 20, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. REVIEW OF SHOCK IMPEDANCE TRENDS SHOWED AN INITIAL RISE IN MEASUREMENTS FOLLOWED BY A PLATEAU, CONSISTENT WITH NORMAL LEAD MATURATION. THE AVERAGE SHOCK IMPEDANCE RANGE WAS 95-100 OHMS, WITH A FEW OUTLIERS. THIS RV LEAD REMAINS IN SERVICE. NORMAL FOLLOW UP AND CONTINUED MONITORING WAS RECOMMENDED AT THIS TIME. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123455 ↗
• InjuryJan 5, 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23960783 ↗
• MalfunctionDec 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND OBSERVED THAT THE MEASUREMENT THAT WAS OUT OF RANGE APPEARS TO BE AN OUTLIER, AS THE OTHER SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE STABLE AND WITHIN RANGE, AND NOTED THAT THERE IS NO EVIDENCE OF NOISE. TS RECOMMENDED PERFORMING ISOMETRICS, POCKET MANIPULATION, AND SERIAL IMPEDANCE TESTS, AND IF NO NOISE IS OBSERVED, THE PATIENT MAY CONTINUE TO BE MONITORED. REPROGRAMMING CAN ALSO BE CONSIDERED. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927439 ↗
• InjuryDec 19, 2025Failure to Read Input Signal; Failure to Read Input Signal

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849452 ↗
• InjuryOct 21, 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23351978 ↗
• InjurySep 5, 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22986962 ↗
• MalfunctionAug 26, 2025High impedance; Off-Label Use; High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A MESSAGE FOR OUT OF RANGE IMPEDANCE MEASUREMENTS WHEN ATTEMPTED TO BE PROGRAMMED INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED AVAILABLE DATA. TS DISCUSSED HOW THE DEVICE SHOULD BE EVALUATED IN PERSON BEFORE PROCEEDING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895287 ↗
• InjuryAug 19, 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22836621 ↗

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