ENDOTAK RELIANCE® 0157Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00802526531125), received between Jan 17, 2017 and Sep 18, 2024 — classified as 2 deaths, 132 injuries, 31 malfunctions.

The most frequently reported specific device problem is “High impedance” (39 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 165 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Defective 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 PACE/SENSE PART WAS SURGICALLY CAPPED. FURTHERMORE, THE OTHER RV LEAD WAS USED FOR PACING AND SENSING. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD INDICATING THAT THIS LEAD PACE/SENSE PART WAS SURGICALLY ABANDONED AS THIS IS A STANDARD OPERATING PROCEDURE FOR THIS ELECTROPHYSIOLOGY AT UPGRADES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244731 ↗
• MalfunctionJul 17, 2024Defective Device; No Apparent Adverse Event; Defective Device; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS TACHY LEAD WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. THIS TACHY LEAD WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761158 ↗
• MalfunctionJun 19, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM RECORDED A CODE 1007 INDICATIVE OF THE CAPACITOR CHARGE TIME EXCEEDING THE LIMIT. THE SYSTEM HAD DELIVERED A SHOCK A FEW DAYS PRIOR TO THE ALERT. IMPEDANCE MEASUREMENTS WERE STABLE BUT THERE IS INSULTATION DAMAGE. THE CRT-D WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151813 ↗
• InjuryMay 25, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE PHYSICIAN DECIDED TO SURGICALLY ABANDON THE PACE AND PORTION SENSE OF THE LEAD AND IMPLANT A NEW RIGHT VENTRICULAR LEAD. THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004885 ↗
• InjuryMay 15, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS BEING OVERSENSED RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY. ADDITIONALLY, THERE WERE SIGNIFICANT CHANGES IN PACING IMPEDANCES. TACHY THERAPY WAS PROGRAMMED OFF. IT WAS NOTED THAT THE RV LEAD WAS FRACTURED. SUBSQUENTLY, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 16930820 ↗
• InjuryMay 8, 2023Adverse 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 SYSTEM REVISION DUE TO ENTEROCOCCAL INFECTION AND SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 16890292 ↗
• MalfunctionMay 3, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED NOISE, OVERSENSING AND PACING INHIBITION OF OVER TWO SECONDS ON THE RIGHT VENTRICULAR CHANNEL. IT WAS DETERMINED THAT THIS WAS DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). ADDITIONALLY ANTI-TACHYCARDIA PACING (ATP) WAS INAPPROPRIATELY DELIVERED. IT WAS DISCUSSED TO CONTACT THE PATIENT IN ORDER TO ADDRESS THE SOURCE OF THE EMI. NO CHANGES WERE PERFORMED ON THE DEVICE. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED DETAILING THAT THE ISSUES WITH THE DEVICE CONTINUE TO APPEAR AND MYOPOTENTIAL OVERSENSING WAS THE MOST LIKELY ROOT CAUSE AND DISCARDED THE IDEA OF EMI. FURTHER EVALUATION OF THE PATIENT WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 16865146 ↗
• InjuryApr 5, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD. THE LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682852 ↗
• InjuryMar 16, 2023Adverse 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 EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16557036 ↗
• InjuryFeb 9, 2023High 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 GREATER THAN 2,500 OHMS AND THRESHOLD MEASUREMENTS OF 5.5V@2MS. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN SINCE 2016, AND THE LAST DEVICE CHECK SHOWED THE FOLLOWING LEAD MEASUREMENTS: PACE IMPEDANCE 1,671 OHMS, THRESHOLDS 2.4V AT 0.4MS, AND SHOCK IMPEDANCE 65 OHMS. NO NOISE WAS OBSERVED AT THAT TIME. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER LEAD EVALUATION, AND DISCUSSED POSSIBLE CAUSES AND TROUBLESHOOTING OPTIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AND REPLACED. IT WAS ALSO NOTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344919 ↗
• MalfunctionFeb 6, 2023Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. THE RA LEAD INVOLVED IS A NON BOSTON SCIENTIFIC PRODUCT. NOISE WAS ALSO OBSERVED. DUE TO THE PATIENT ENTERING HOSPICE CARE, IT WAS DECIDED BY THE HEALTH CARE TEAM TO DEACTIVATE THE TACHY THERAPY FOR THIS PATIENT. IT IS PLANNED TO DISCUSS TROUBLESHOOTING AND FOLLOW UP WITH THE PHYSICIAN IN CHARGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309200 ↗
• InjuryJan 11, 2023Adverse 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 16136851 ↗
• InjuryJan 4, 2023Adverse 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 16097421 ↗
• InjuryDec 14, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. THE LEAD WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977110 ↗
• InjuryNov 29, 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 15882551 ↗
• MalfunctionNov 8, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. NO NOISE AND NO CONCERNS FOR LEAD FAILURE. 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 15752288 ↗
• InjuryOct 31, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING DEVICE REPLACEMENT THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND EXHIBITING HIGH SHOCK IMPEDANCES OUT OF RANGE. THE RV LEAD HAS BEEN IMPLANTED FOR NINETEEN YEARS AND IT IS SUSPECTED CALCIFICATION AS THE CAUSE. SUBSEQUENTLY, THE RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700927 ↗
• MalfunctionOct 25, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH, OUT-OF-RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS. IT WAS NOTED THERE WERE NO OBSERVATIONS OF NOISE. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND RECOMMENDED TO EVALUATE THE PATIENT IN THE CLINIC AND RESET THE ALERT CONDITION. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666858 ↗
• InjurySep 22, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH OUT OF RANGE IMPEDANCE OF GREATER THAN 2500 OHMS AND FAILURE TO CAPTURE. THE CAUSE OF HIGH IMPEDANCE AND FAILURE TO CAPTURE IS UNKNOWN. CUSTOMER PERFORMED PSA TESTING TO CONFIRM THE REPORTED ALLEGATIONS. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15465311 ↗
• InjurySep 22, 2022No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464765 ↗
• InjurySep 2, 2022High impedance; Low impedance; Material Integrity Problem; High impedance; Low impedance; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD TRIGGERED AN ALERT DUE TO A LOW OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT OF 13 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER EVALUATION TO RULE OUT A POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE OR CONSIDER A SYNCH MAX ENERGY SHOCK TO RULE OUT ANY SHORTED CONDITION. SHOCK LEAD TRENDS FROM A FEW WEEKS PRIOR NOTE A DIP IN MEASUREMENTS FROM 50 OHMS TO 35 OHMS, WHICH MAY SUGGEST THE LOW READING WAS NOT LIKELY ATTRIBUTED TO EMI. IT WAS NOTED THAT NO SHOCKS HAVE BEEN DELIVERED SINCE IMPLANT. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349283 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. A DIFFERENT IMPLANTED RV LEAD IS USED FOR THE PACING/SENSING. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306460 ↗
• InjuryAug 24, 2022Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO DELIVERING INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) CAUSE BY NOISE OVERSENSING. A FRACTURE WAS SUSPECTED AS THE MAIN CAUSE. THE NOISE WAS REPRODUCIBLE WITH MYOPOTENTIALS, AND THE PHYSICIAN DECIDED TO REPLACE IT WITH A NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287650 ↗
• InjuryAug 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. WHEN THE PHYSICIAN EXPLANTED THE RIGHT ATRIAL (RA) LEAD, THE RV TISSUE INGROWTH PULLED THE RV LEAD AND WAS DISLODGED. AS A RESULT, A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237113 ↗
• InjuryJul 29, 2022Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, WHICH WAS OVERSENSED RESULTING IN THE DELIVERY OF ONE ROUND OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY. IT WAS NOTED THAT THERE WERE NO ADVERSE EFFECTS ON THE PATIENTS HEALTH STATUS AS A RESULT OF THE INAPPROPRIATE THERAPY. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129286 ↗

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-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-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