ENDOTAK RELIANCE® S 640263-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00802526601835), received between Jan 23, 2020 and Jul 10, 2026 — classified as 8 injuries, 7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Defibrillation/Stimulation Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A SYNCOPAL EPISODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED UNDERSENSING, WHICH RESULTED IN THE RHYTHM REMAINING BELOW THE RATE CUTOFF (RCO) CRITERIA REQUIRED FOR THERAPY DELIVERY. TS PROVIDED TROUBLESHOOTING RECOMMENDATIONS AND ADVISED CONSIDERATION OF RV LEAD REVISION TO OPTIMIZE SENSING PERFORMANCE. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25774540 ↗
• InjuryJun 13, 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22207032 ↗
• InjuryJul 10, 2024Adverse 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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 19709474 ↗
• MalfunctionJan 6, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, HIGH CAPTURE THRESHOLD MEASUREMENTS WERE ALSO NOTED. AT THIS TIME THE PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114279 ↗
• MalfunctionDec 15, 2022Signal Artifact/Noise; Failure to Capture; High impedance; Failure to Read Input Signal; Under-Sensing; Signal Artifact/Noise; Failure to Capture; High impedance; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS, A DROP IN INTRINSIC AMPLITUDE, NOISE, INTERMITTENT LOSS OF CAPTURE, AND INTERMITTENT UNDERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS NOTED GRADUAL INCREASING RV LEAD IMPEDANCE OF ABOUT 900 OHMS OVER THE LAST THREE MONTHS. THE PHYSICIAN PLANS TO HAVE THE PATIENT COME IN FOR FURTHER EVALUATION. THE DEVICE AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992667 ↗
• InjuryNov 4, 2022No Apparent Adverse Event; High Capture Threshold; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO PRODUCT PERFORMANCE ISSUES. 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 15731694 ↗
• InjuryApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107323 ↗
• MalfunctionJan 27, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE GREATER THAN 2,000 OHMS. FLUOROSCOPY DID SHOW GOOD LEAD PLACEMENT DESPITE THE IMPEDANCE. IT WAS REPORTED THAT THE LEAD WAS TESTED ON A PACING SYSTEM ANALYZER (PSA) AFTER INITIAL PLACEMENT, AND PACING IMPEDANCE MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL LIMITS. UPON CONNECTION OF THE LEAD TO THE IMPLANTED DEVICE, OUT OF RANGE MEASUREMENTS GREATER THAN 2,000 OHMS WERE OBSERVED. THE LEAD WAS THEN DISCONNECTED FROM THE DEVICE AND AGAIN TESTED ON THE PSA. MEASUREMENTS ON THE PSA WERE THEN ALSO GREATER THAN 2,000 OHMS. THE LEAD WAS ATTEMPTED, BUT NOT IMPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377141 ↗
• MalfunctionJul 28, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS TACHY LEAD WAS AN ATTEMPTED IMPLANT DUE TO HIGH PACING IMPEDANCE. A POSSIBLE FRACTURE WAS NOTED WHERE SUTURE WAS TIED DOWN VERY TIGHTLY. THE LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243409 ↗
• MalfunctionJun 23, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A GRADUAL RISE IN RIGHT VENTRICULAR (RV) PACING IMPEDANCES MEASURING GREATER THAN 2000 OHMS. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12054336 ↗
• InjuryApr 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. REASONABLE EVIDENCE SUGGESTS THIS LEAD EXHIBITED A MALFUNCTION. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662259 ↗
• MalfunctionNov 11, 2020High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED IMPLANT DUE TO HIGH OUT-OF-RANGE IMPEDANCE GREATER THAN 2,000 OHMS. IT WAS SUSPECTED THAT THE LEAD WAS DEFECTIVE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10823230 ↗
• MalfunctionApr 27, 2020Signal Artifact/Noise; Over-Sensing; Defective Device; Signal Artifact/Noise; Over-Sensing; Defective Device

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE PRIOR TO WOUND CLOSURE THIS ATTEMPTED RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND NOISE AND AS A RESULT OF THE PHYSICIAN DAMAGED THE LEAD INSULATION WHILE SUTURING THE LEAD DOWN. SUBSEQUENTLY, THIS RV LEAD WAS REMOVED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10000992 ↗
• InjuryApr 21, 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 PART OF A SYSTEM REVISION DUE TO INFECTION. THIS RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9982498 ↗
• InjuryJan 23, 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 PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9624346 ↗

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-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
• 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