ENDOTAK RELIANCE® S 0138Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00802526531118), received between Apr 22, 2016 and Sep 30, 2026 — classified as 82 injuries, 34 malfunctions.

The most frequently reported specific device problem is “High impedance” (23 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 116 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50942454 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Material Integrity Problem

  It was reported that the implantable cardioverter defibrillator (ICD) and this right ventricular (RV) lead delivered inappropriate anti-tachycardia pacing (ATP) and a single shock due to oversensing of noise. The patient had a strong underlying rhythm, and no pacing inhibition was noted. The field representative (rep) didn't know what the patient was doing when the noise was recorded. Technical Services (TS) discussed troubleshooting options to reproduce the noise and recommended asking what the patient was doing at the time of the shock. This RV lead remains in service. No adverse patient effects were reported.Additional information was received from the field. The patient was seen in clinic and the physician suspected subclavian crush. The ICD was explanted and replaced. This RV lead was surgically abandoned and replaced. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50326257 ↗
• InjuryAug 17, 2026Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient with this right ventricular (RV) lead underwent a surgical intervention to reposition the lead as sensing had decreased possibly due to a microdislodgement. The RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287269 ↗
• InjuryAug 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 50207594 ↗
• MalfunctionMay 27, 2026Failure to Capture; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH CAPTURE THRESHOLDS WITH LOSS OF CAPTURE (LOC) RECENTLY AFTER BEING IMPLANTED. TECHNICAL SERVICES MENTIONED THEY COULD NOT SEE T WAVES AT RV ELECTROGRAM (EGM) AND R WAVES HAD DROPPED IN AMPLITUDE. AN EVALUATION IN CLINIC WITH SURFACE EGM WAS RECOMMENDED. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296912 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted and replaced due to a nonspecific product performance anomaly. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916010 ↗
• InjuryMar 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 24569186 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PARTIALLY SURGICALLY ABANDONED DURING THE IMPLANT PROCEDURE. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED, AND THE SHOCK PORTION REMAINS IN SERVICE. THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318274 ↗
• InjuryFeb 6, 2026Signal Artifact/Noise; Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IS EXHIBITING CROSSTALK OVERSENSING. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED REPROGRAMMING OPTIONS. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED, XRAYS WERE PERFORMED AND THE LEAD WAS FOUND TO HAVE DISLODGE. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278325 ↗
• InjuryJan 14, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND SURGICALLY ABANDONED THE SAME DAY IT WAS IMPLANTED, BUT NO SPECIFIC DETAILS FOR THE REASON HAVE BEEN PROVIDED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070302 ↗
• InjuryJan 12, 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 ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 24045316 ↗
• InjuryDec 29, 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 EXPLANTED DUE TO A NON-PRODUCT EXPERIENCE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918176 ↗
• MalfunctionOct 30, 2025Failure to Capture; Failure to Read Input Signal; Low impedance; Failure to Capture; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THE IMPLANTED DEVICE ALERTED DUE TO LOW, OUT-OF-RANGE (OOR) RIGHT VENTRICULAR (RV) PACE IMPEDANCE. THE VALUE HAD DECREASED FROM APPROXIMATELY 500 OHMS TO 221 OHMS BEFORE DECREASING FURTHER OOR. IT WAS ALSO OBSERVED THAT THE R-WAVE AMPLITUDE HAD DECREASED FROM 25 MV TO 9 MV AND THE THRESHOLD TEST STOPPED RUNNING. THE PRESENTING ELECTROGRAM DEMONSTRATED POSSIBLE RV LOSS OF CAPTURE. THE SHOCK CHANNEL ELECTROGRAM (EGM) WAS ALSO NEGATIVE AND NOT LIKE PRIOR PRESENTING EGMS. TECHNICAL SERVICES DISCUSSED THE POSSIBILITY OF DISLODGMENT OR PERFORATION AND RECOMMENDED EVALUATION OF THE PATIENT IN-CLINIC WITH X-RAY IMAGING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427520 ↗
• InjuryOct 16, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE, OVERSENSING, AND PACING INHIBITION ON THE RIGHT VENTRICULAR (RV) CHANNEL. IT WAS CONFIRMED BY X-RAY THAT THE RV LEAD WAS TOUCHING THE COIL OF A NON-BOSTON SCIENTIFIC OUT OF SERVICE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317461 ↗
• MalfunctionSep 18, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS RV LEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085265 ↗
• InjuryAug 26, 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 A POCKET EROSION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 22895529 ↗
• InjuryAug 18, 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 A SEPSIS AND INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS ADMITTED FOR POSITIVE BLOOD CULTURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22833427 ↗
• InjuryAug 13, 2025Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Device Contamination with Body Fluid; Defective Device; Contamination /Decontamination Problem; Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Device Contamination with Body Fluid; Defective Device; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SCHEDULED FOR LEAD REVISION DUE TO OVERSENSED NOISE FROM CONTACT WITH THE LEFT BUNDLE BRANCH (LBB) LEAD. THE PATIENT'S EXTREME TRICUSPID VALVE REGURGITATION REQUIRED MULTIPLE FIXATION ATTEMPTS. AT ONE POINT, TISSUE BECAME ENTRAPPED IN THE HELIX MECHANISM AND REQUIRED MORE THAN 30 TURNS TO GET THE HELIX TO RETRACT. SUBSEQUENTLY BOTH THE RV AND LBB LEADS WERE EXPLANTED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798366 ↗
• MalfunctionAug 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS, VALUES STARTED IN THE 60 OHM RANGE AND MOST RECENTLY WERE IN THE 80 OHM RANGE. PHYSICIAN FOLLOW-UP PLANNED FOR RESOLUTION. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755374 ↗
• MalfunctionJul 1, 2025Signal Artifact/Noise; Failure to Sense; Signal Artifact/Noise; Failure to Sense

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS NOT IMPLANTED SUCCESSFULLY DUE TO LACK OF SENSING AND NOISE ON THE LEAD. A NEW RV LEAD WITH THE SAME MODEL WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379494 ↗
• InjuryJul 1, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. OTHER THAN THE PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373405 ↗
• InjuryJun 24, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT A PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. TWO IMPLANTABLE LEADS OF THE SAME MODEL WERE ATTEMPTED ON THIS REVISION PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324495 ↗
• MalfunctionJun 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PRODUCED OVERSENSING. THE MEASUREMENTS LATER ON, RESOLVED ON ITS OWN. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190303 ↗
• InjuryMay 21, 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 POCKET INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22061446 ↗
• InjuryMay 21, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058052 ↗

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,