ENDOTAK RELIANCE® S 0128Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526085505), received between Apr 3, 2020 and Jul 17, 2026 — classified as 5 injuries, 4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ABOVE 150 OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED AND PROGRAMMING ENHANCEMENTS AS WELL AS CONTINUED MONITORING WAS RECOMMENDED. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864000 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) APEX LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV APEX LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16277445 ↗
• MalfunctionDec 8, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD SHOCK LEAD IMPEDANCE VALUES (SLI) RANGING FROM 110 TO 120 OHMS WHEN TESTED IN CLINIC. THE PATIENT'S DEVICE DISPLAYED SLI OF GREATER THAN 150 OHMS. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING INCLUDING RECOMMENDING A COMMANDED SHOCK TEST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941193 ↗
• InjuryMay 25, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACE IMPEDANCE MEASUREMENTS THAT REMAINED WITHIN NORMAL RANGE AND HIGH THRESHOLD MEASUREMENTS. A NEW RV LEAD WAS IMPLANTED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14500421 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEAD WAS A CASE OF AN ATTEMPTED IMPLANT. ADDITIONAL INFORMATION THE IMPLANTING PHYSICIAN PERFORATED THE SUBCLAVIAN VESSEL AND WAS FOUND WHEN TRYING TO ADVANCED THE LEAD. THE PATIENT STARTED TO FEEL PAIN AND THE PHYSICIAN DID A VENOGRAM AND NOTED THE PERFORATION OF THE VESSEL. THE LEAD WAS NEVER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain; Perforation

  MAUDE report 11791650 ↗
• InjuryApr 13, 2021Signal Artifact/Noise; High impedance; Material Integrity Problem; High Capture Threshold; Signal Artifact/Noise; High impedance; Material Integrity Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS PARTIALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION PROVIDED INDICATES THAT THIS LEAD'S PACE/SENSE PORTION WAS SURGICALLY ABANDONED AS THE LEAD HAS BEEN UNDER OBSERVATION BY THE CLINIC SINCE MARCH OF 2020 DUE TO INCREASING HIGH OUT OF RANGE PACING IMPEDANCES. ALSO, THIS LEAD EXHIBITED NOISE ON A STORED EVENT, AS WELL AS RISING THRESHOLDS. IN ADDITION, IT WAS SUSPECTED BY THE PHYSICIAN THAT THE LEAD WAS POTENTIALLY DAMAGED DUE TO SUBCLAVIAN CRUSH, HOWEVER, THERE WERE NO VISIBLE SIGNS OF FRACTURE OR CRUSH OBSERVED UNDER FLUOROSCOPY. SUBSEQUENTLY, DURING THE PULSE GENERATOR CHANGE OUT DUE TO ELECTIVE REPLACEMENT INDICATOR, THIS LEAD WAS FIXED AND THE SHOCKING PORTION REMAINS IN SERVICE. A NEW PACE/SENSE LEAD WAS IMPLANTED TO SUBSTITUTE THE ABANDONED PACE/SENSE PORTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662255 ↗
• InjuryJan 2, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT OF 2,500 OHMS. THERE WAS ALSO AN INCREASE IN THE PACING THRESHOLD MEASUREMENT. NO LOSS OF CAPTURE WAS REPORTED. SUBSEQUENTLY, THIS PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS RV LEAD WAS SURGICALLY CAPPED/ABANDONED. IT WAS NOTED THERE WAS NO EVIDENCE OF A LEAD FRACTURE ON X-RAY IMAGING. A NEW RV LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 11105110 ↗
• MalfunctionOct 6, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. X-RAY IMAGING WAS UNREMARKABLE, AND IN-CLINIC MANIPULATIONS HAVE BEEN UNSUCCESSFUL AT REPRODUCING THE HIGH IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED ADDITIONAL LEAD INTEGRITY TESTING TO RULE OUT LEAD IMPAIRMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION FROM THE FIELD INDICATES NO PROGRAMMING CHANGES HAVE BEEN MADE AT PRESENT, AND THIS PATIENT WILL BE CLOSELY MONITORED VIA THE LATITUDE REMOTE PATIENT MONITORING SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10636942 ↗
• MalfunctionApr 3, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS AN ATTEMPTED IMPLANT DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LEAD WAS RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925157 ↗

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-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,