ENDOTAK RELIANCE® 0265Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00802526431289), received between Jul 11, 2017 and Dec 22, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT INTO THE CLINIC AND ISOMETRIC TESTING WAS PERFORMED. THE RV PACE THRESHOLDS AND SENSING WERE STABLE AND NO NOISE WAS NOTED ON THE LEAD OR IN ANY STORED EVENTS. THE PLAN IS CONTINUE MONITORING. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873469 ↗
• MalfunctionFeb 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS, WITH THE INCREASE BEEN GRADUAL. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THERAPY DELIVERY AS WELL AS DEVICE PROGRAMMING. PATIENT WILL CONTINUE TO BE MONITORED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459872 ↗
• MalfunctionNov 21, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THRESHOLD MEASUREMENTS WERE ALSO NOTED TO HAVE INCREASED SLIGHTLY TO 2V. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THIS COULD BE DUE TO CHANGES IN LEAD TISSUE INTERFACE WITH THE TIP ELECTRODE DUE TO SCAR TISSUE OF CALCIFICATION. TS RECOMMENDED TO CONTUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749925 ↗
• InjuryJan 2, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO EXHIBITING NOISE, OVERSENSING AND PACING INHIBITION. INSULATION DAMAGE ALONG THE LEAD BODY WAS SUSPECTED. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 18431217 ↗
• InjuryNov 17, 2023Signal Artifact/Noise; High impedance; High Capture Threshold; Signal Artifact/Noise; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCES OUT OF RANGE ON SEVERAL CHECKS, ELEVATED THRESHOLDS, AND NOISE SIGNALS. THE PHYSICIAN ELECTED TO REPLACE THE RV LEAD WITH A NEW ONE AND SURGICALLY ABANDONED THE EXISTING. A FLUOROSCOPY WAS PERFORMED AT IMPLANT, BUT THERE WAS NOTHING DETECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162049 ↗
• InjuryNov 9, 2022Adverse 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15759058 ↗
• InjuryMar 14, 2019High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY CAPPED AND REPLACED DUE TO OBSERVATIONS OF HIGH OUT OF RANGE IMPEDANCES GREATER THAN 2000 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8421935 ↗
• MalfunctionJul 11, 2017Fracture; High impedance; Ambient Noise Problem; Fracture; High impedance; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE WARRANTY DEPARTMENT THAT THIS LOCAL REPRESENTATIVE WAS CONTACTED BY A HOSPITAL STAFF MEMBER VIA PHONE MESSAGE. THE STAFF MEMBER WAS INQUIRING ABOUT BOSTON SCIENTIFIC'S INDIGENT PROGRAM. THE PATIENT WAS HOSPITALIZED AND HAS NO INSURANCE. THE PATIENT HAS A NON-BOSTON SCIENTIFIC DEVICE AND A BOSTON SCIENTIFIC LEAD THAT HAS MALFUNCTION. THE PHYSICIAN INTENDS TO REPLACE THE IMPLANT LEAD AND THE HOSPITAL WAS LOOKING FOR AN INDIGENT DONATION. NO PATIENT NAME OR IMPLANTED PRODUCT INFORMATION WAS PROVIDED TO THE LOCAL REPRESENTATIVE. THE SPECIFIC LEAD MALFUNCTION WAS NOT IDENTIFIED AND THE LEAD CURRENTLY REMAINS IN-SERVICE. THE LOCAL REPRESENTATIVE WAS TRANSFERRED TO THE PERSON IN CUSTOMER SERVICES WHO COORDINATES THE INDIGENT PROGRAM. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE WAS ABLE TO IDENTIFY THE PATIENT NAME AND MODEL#/SN# OF THE IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. ACCORDING TO THE LOCAL REPRESENTATIVE, THIS RV DEFIBRILLATION LEAD WAS EXHIBITING HIGH RV PACING IMPEDANCE AND ELECTROGRAM NOISE. THE PHYSICIAN SUSPECTS A LEAD CONDUCTOR FRACTURE. THE LOCAL REPRESENTATIVE HAS NOT BEEN NOTIFIED OF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6701061 ↗

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