ENDOTAK RELIANCE® 0266Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00802526431296), received between Apr 19, 2017 and Sep 4, 2026 — classified as 16 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602230 ↗
• MalfunctionOct 27, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE PATIENT WAS RECENTLY IMPLANTED WITH AN ADDITIONAL CONCOMITANT DEVICE. TECHNICAL SERVICES (TS) WAS CALLED FORA CONSULT REVIEW OF THE PRESENTING ELECTROGRAM (EGM). UPON REVIEW, THE PRESENTING EGM SHOWED THERE TO BE 3.5 SECONDS OF ASYSTOLE THAT APPEARED TO HAVE BEEN CAUSED BY OVERSENSED MYOPOTENTIAL NOISE. THE HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE NOISE WAS REPRODUCED IN THE CLINIC. TS DISCUSSED PROGRAMMING OPTIMIZATION OPTIONS WITH THE HCP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME THIS CRT-D AND RV LEAD REMAIN IN SERVICE.

  Patient problems: Asystole

  MAUDE report 23393445 ↗
• InjuryMay 15, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS AS WELL AS HIGH OUT OF RANGE PACING IMPEDANCE MEASURING 2040 OHMS. THE PHYSICIAN OPTED TO SURGICALLY ABANDON AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024930 ↗
• MalfunctionDec 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW STORED VENTRICULAR EPISODES THAT TRIGGERED EIGHT ANTI-TACHYCARDIA PACING (ATP) BURST ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE ATP THERAPY SUCCESSFULLY CONVERTED THE RHYTHM. ADDITIONALLY, TECHNICAL SERVICES (TS) OBSERVED THE HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021171 ↗
• MalfunctionAug 14, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE LEADS CAPACITY TO CONVERT THE PATIENTS RHYTHM WITH A SHOCK. TS CLARIFIED LOC WON'T AFFECT THE DELIVERY OF ANY SHOCKS, BUT SINCE A DEFIBRILLATION THRESHOLD (DFT) TEST HAS NEVER BEEN CONDUCTED, THE ABILITY OF A SHOCK TO CONVERT THE PATIENT HAS NOT BEEN TESTED AND CONFIRMED. INFORMATION FROM THE FIELD INDICATES THE PATIENT WILL CONTINUE TO BE MONITORED SINCE THEY DO NOT REQUIRE PACING. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983144 ↗
• InjuryNov 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088098 ↗
• MalfunctionApr 27, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827356 ↗
• InjuryNov 18, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO NOISE. THE PHYSICIAN DETERMINED THAT REPROGRAMMING WAS NOT SUFFICIENT AND THERE WAS CONCERN FOR POTENTIAL INAPPROPRIATE THERAPY. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828141 ↗
• MalfunctionOct 13, 2022Signal Artifact/Noise; Over-Sensing; Defective Device; Signal Artifact/Noise; Over-Sensing; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WERE AN ATTEMPTED IMPLANT DUE TO NOISE AS A RESULT OF AIR BUBBLES. IT WAS NOTED THAT THE SEALING RINGS APPEARED TO HAVE A HOLE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING THE AIR BUBBLES INCLUDING BURPING THE DEVICE HEADER AND CHECKING THE SEALING RINGS. THE PHYSICIAN HOWEVER, REQUESTED A NEW DEVICE BE PLACED AT WHICH POINT THE SAME PHENOMENON OCCURRED. THE PHYSICIAN THEN REQUESTED A DIFFERENT RIGHT VENTRICULAR (RV) LEAD BE IMPLANTED. THAT RV LEAD WAS CONNECTED TO THE NEW DEVICE AND THE ISSUES SUBSIDED. IT WAS THOUGHT THAT THE FIRST RV LEAD MAY HAVE BEEN TIGHT NEAR THE CLAVICLE HOWEVER, THE LEAD HAD MEASURED WELL. THE NEW ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595877 ↗
• MalfunctionOct 6, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. IT WAS NOTED THAT THAT SENSING WAS 10.4MV AND THRESHOLD WAS 0.8V. THIS ICD SYSTEM REMAINS IN SERVICE. IT WAS AT THE PHYSICIAN'S DISCRETION REGARDING CONTINUED MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548296 ↗
• InjurySep 26, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED DUE TO LOSS OF CAPTURE (LOC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483753 ↗
• InjuryJan 28, 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 13387328 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED 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 12272004 ↗
• MalfunctionOct 2, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A GRADUAL INCREASE IN PACING IMPEDANCE MEASUREMENTS EVENTUALLY RESULTING IN HIGH OUT OF RANGE MEASUREMENTS GREATER THAN 2,000 OHMS. CALCIFICATION ON THE LEAD TIP WAS SUSPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE OPTION OF INCREASING THE ALERT VALUE IN THE REMOTE HOME MONITORING SYSTEM AND CONTINUING MONITORING. THE PHYSICIAN OPTED TO INCREASE THE ALERT VALUE IN THE REMOTE HOME MONITORING SYSTEM AND MONITORING WILL BE CONTINUED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10620196 ↗
• InjuryOct 1, 2020Adverse 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 EXPLANTED DUE TO OTHER/ON PRODUCT EXPERIENCE. THIS LEAD REMAINED IN SERVICE FOR 15 MONTHS AND IT WAS EXPLANTED ALONG WITH THE PACEMAKER DEVICE. REASONABLE EVIDENCE SUGGESTS THIS LEAD EXHIBITED A MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10616760 ↗
• InjuryApr 3, 2020High impedance; High impedance

  IT WAS REPORTED THAT OVER THE PAST YEAR, THE RIGHT VENTRICULAR (RV) LEAD HAS BEEN EXHIBITING A GRADUAL INCREASE IN PACE IMPEDANCES. THESE PACE IMPEDANCE MEASUREMENTS ARE HIGH AND OUT OF RANGE FOR THIS LEAD. THE OTHER RV LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE, INCLUDING THE SHOCK IMPEDANCE. A NIPS STUDY WAS PERFORMED AND THE DEVICE IS PERFORMING AS PROGRAMMED. TECHNICAL SERVICES WAS CONSULTED AND RECOMMENDED PROGRAMMING CHANGES. TECHNICAL SERVICES DISCUSSED THERE MAY BE CALCIFICATION ONLY ON THE TIP OF THE LEAD AND NOT THE COIL, WHICH IS WHY YOU WOULD SEE NO CHANGES IN THE SHOCK IMPEDANCE. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9924768 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9921144 ↗
• InjuryNov 2, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD. IT WAS ALSO NOTED THAT THE PATIENT HAD AN INFECTION. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9270451 ↗
• InjuryNov 2, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT A TRICUSPID VALVE REPAIR. THE DEVICE WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure; Ventricular Tachycardia

  MAUDE report 9270139 ↗
• InjuryNov 2, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS TETHERED INTO THE VALVE. THE PHYSICIAN CUT THE LEAD AT THE SUPERIOR VENA CAVA (SVC). THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure; Ventricular Tachycardia

  MAUDE report 9270129 ↗
• InjuryJul 31, 2019Pacing Problem; Device Dislodged or Dislocated; Pacing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY REPOSITIONED DUE TO MICRO DISLODGEMENT WHICH CAUSED THE PACING TO NOT BE DELIVERED WHEN REQUIRED. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847614 ↗
• InjuryJul 10, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO PRODUCT PERFORMANCE ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778195 ↗
• InjuryOct 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE PATIENT HAS A PROBLEMATIC PHYSIOLOGY, FOR THAT REASON THE PHYSICIAN DECIDED TO EXPLANT THIS LEAD AND PLACED A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7977550 ↗
• InjuryApr 19, 2017Failure to Capture; Capturing Problem; Device Operates Differently Than Expected; Failure to Capture; Capturing Problem; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT THIS RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED DEVICE EXPERIENCED SYNCOPE. THE SYSTEM DISPLAYED A RISE IN PACING THRESHOLD MEASUREMENTS AND INTERMITTENT LOSS OF CAPTURE (LOC) WHICH, AT TIMES, INDUCED VENTRICULAR TACHYCARDIA (VT). THE VT WAS TERMINATED WITH ANTI-TACHYCARDIA PACING (ATP). IT WAS REPORTED THAT THE SYSTEM AND PATIENT WOULD CONTINUED TO BE MONITORED.

  Patient problems: Syncope

  MAUDE report 6503961 ↗

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-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,