ENDOTAK RELIANCE® S 640272-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 516 adverse event reports that list this exact device (DI 00802526601804), received between Apr 16, 2019 and Sep 30, 2026 — classified as 3 deaths, 390 injuries, 123 malfunctions.

The most frequently reported specific device problem is “High impedance” (87 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 516 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) had an episode of pacemaker mediated tachycardia (PMT). Technical Services (TS) was consulted and reviewed stored data. TS noted there was an isolated instance of oversensing of noisy signals for its right ventricular (RV) lead. TS discussed troubleshooting options and recommended further in clinic examination. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947729 ↗
• InjurySep 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 explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50872730 ↗
• InjurySep 11, 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 50734241 ↗
• InjuryAug 14, 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 50263475 ↗
• InjuryJul 31, 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 50104904 ↗
• MalfunctionJul 10, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS TRIGGERED MULTIPLE ALERTS FOR HIGH, OUT OF RANGE SHOCK IMPEDANCES. TECHNICAL SERVICES RECOMMENDED INCREASING ALERT THRESHOLD TO 175 OHMS AND MONITOR. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783736 ↗
• MalfunctionJun 24, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE WAS FOUND TO BE HIGH AND OUT OF RANGE. CONTINUED MONITORING WAS RECOMMENDED BY TECHNICAL SERVICES. ADDITIONAL SUGGESTIONS INCLUDED ENABLING NONSUSTAINED VENTRICULAR TACHYCARDIA ALERTS IN THE LATITUDE NXT MONITORING SYSTEM AND ADJUSTING THE UPPER LIMIT FOR RV PACING IMPEDANCE TO ALLOW FOR A HIGHER THRESHOLD. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612108 ↗
• InjuryJun 24, 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 25610836 ↗
• InjuryJun 16, 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 25524902 ↗
• InjuryJun 4, 2026Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, WHICH RESULTED IN PACING INHIBITION. LOW AMPLITUDE WAS ALSO OBSERVED; THEREFORE, SENSITIVITY WAS REPROGRAMMED. TECHNICAL SERVICES (TS) WAS CONSULTED AND DEFIBRILLATION THRESHOLD (DFT) TEST WAS DISCUSSED AS AN OPTION TO ENSURE APPROPRIATE VENTRICULAR ARRHYTHMIA SENSING. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25399411 ↗
• InjuryJun 4, 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 25394963 ↗
• InjuryJun 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25379549 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to systemic infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25372510 ↗
• InjuryMay 12, 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 25147665 ↗
• MalfunctionMay 11, 2026Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE. TECHNICAL SERVICES (TS) REVIEWED THE EPISODE AND DETERMINED THERE WERE WIDE SIGNALS ON THE ELECTROGRAM, WITH ONE SIGNAL APPEARING ON ALL CHANNELS WITH NO KNOWN SOURCE. TS ALSO NOTED DOUBLE COUNTING OF AN INDIVIDUAL BEAT ON THE RIGHT VENTRICULAR CHANNEL. LEAD DIAGNOSTICS WERE STABLE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135454 ↗
• InjuryMay 4, 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 25071971 ↗
• MalfunctionApr 27, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENT. TECHNICAL SERVICES (TS) WAS CONSULTED AND INDICATED THAT THE OVERALL SHOCKING IMPEDANCE TREND WAS STABLE, ALTHOUGH VARIABLE VALUES AROUND 120 OHMS WERE NOTED. NO NOISE EVENTS WERE OBSERVED FROM REVIEWED EPISODES. TS RECOMMENDED PERFORMING ISOMETRIC TESTING AND SUGGESTED INCREASING THE OUT OF RANGE UPPER LIMIT TO 150 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009593 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24948566 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem; 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 DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD DID NOT EXHIBITED ANY PRODUCT MALFUNCTION AND THE PROCEDURE WAS PERFORMED DUE TO A THERAPY UPGRADE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865820 ↗
• InjuryApr 10, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN ELEVATED PACING THRESHOLD OF 1.3 VOLTS AT 0.4 MILLISECOND. THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A NON-BOSTON SCIENTIFIC MODEL LEAD AND WAS DISPOSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845007 ↗
• InjuryApr 6, 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 24790319 ↗
• MalfunctionMar 4, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) IN THE LEFT VENTRICULAR (LV) LEAD. IN ADDITION, HIGH THRESHOLD VALUES WERE NOTED FOR BOTH THE LV AND RIGHT VENTRICULAR (RV) LEADS. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514176 ↗
• InjuryFeb 27, 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 CHRONIC SEPSIS AND VEGETATION ON THE LEADS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24476843 ↗
• InjuryFeb 23, 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 24422964 ↗
• MalfunctionFeb 12, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS FOR ITS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS HOW TO CLEAR THE ALERT FOR THE MEASUREMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324639 ↗

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-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-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