ENDOTAK RELIANCE® 0275Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00802526531224), received between Oct 12, 2016 and Sep 9, 2026 — classified as 70 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (14 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696282 ↗
• InjuryAug 24, 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 50420734 ↗
• MalfunctionAug 11, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210997 ↗
• MalfunctionMay 7, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCES OUT OF RANGE GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) REVIEWED AND NOTED THAT THE VALUES HAD BEEN TYPICALLY STABLE AROUND 40 OHMS AND THERE WERE ONLY TWO OCCURRENCES OUT OF RANGE. IT WAS NOTED THAT REPROGRAMING WAS PERFORMED AFTER INDIVIDUAL VECTOR BREAKDOWN EVALUATION. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112234 ↗
• MalfunctionOct 21, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK PACING IMPEDANCE MEASUREMENTS. UPON REVIEW, IT WAS NOTED A GRADUAL RISE OF THE SHOCK MEASUREMENTS, WHICH WAS BELIEVED TO BE CAUSED BY CALCIFICATION. THE PLAN IS CONTINUE MONITORING. CURRENTLY, THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 23351688 ↗
• InjurySep 5, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22983678 ↗
• InjuryApr 22, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21882707 ↗
• InjuryApr 17, 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 21853001 ↗
• MalfunctionMar 19, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD WHILE THE PATIENT WAS ASLEEP, WHICH CAUSED FOUR SECONDS OF ASYSTOLE DUE TO PACING INHIBITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 21643523 ↗
• InjuryMar 19, 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 21640452 ↗
• InjuryDec 12, 2024Unexpected Therapeutic Results; Device Dislodged or Dislocated; Unexpected Therapeutic Results; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD RECEIVED THREE SHOCKS. THE FIRST SHOCK WAS GIVEN FOR A RHYTHM THAT THE PHYSICIAN DEEMED NON LIFE-THREATENING. THE SECOND SHOCK MADE THE SITUATION WORSE, AND THE THIRD SHOCK CONVERTED. THE PHYSICIAN STATED THAT THE WIRE WAS IN THE WRONG PLACE. THE DEVICE WAS PROGRAMMED OFF, THE PATIENT WAS GIVEN A LIFE VEST, AND LEAD REVISION WAS PLANNED FOR JANUARY 2025. IT WAS NOTED THAT THE PATIENT WAS PART OF A STUDY WITH ADDITIONAL SOFTWARE. TECHNICAL SERVICES (TS) WAS UNAWARE OF THE WHAT TRIAL THE PATIENT WAS IN, AND RECOMMENDED THAT THE PHYSICIAN FOLLOW UP WITH THE CLINICAL TRIAL ABOUT THE ADDITIONAL SOFTWARE. THIS RV LEAD REMAINS IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 20916769 ↗
• InjuryNov 26, 2024Failure to Capture; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO EXHIBIT INAPPROPRIATE SHOCK, HIGH PACING THRESHOLDS, LOSS OF CAPTURE (LOC) DUE TO DISLODGEMENT. A LEAD REVISION PROCEDURE WAS PERFORMED, THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20779899 ↗
• MalfunctionOct 31, 2024Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY STORED A SIGNAL ARTIFACT MONITOR (SAM) EPISODE AND DISABLED THE MINUTE VENTILATION (MV) SENSOR THE DAY AFTER THE IMPLANT PROCEDURE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING. ON THE SAM EPISODE IT WAS NOTED THE RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCES WERE LOW OUT OF RANGE DUE TO THE EMI. TECHNICAL SERVICES (TS) DISCUSSED REPROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579648 ↗
• InjuryOct 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 SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20414640 ↗
• InjuryJun 26, 2024Signal Artifact/Noise; Pacing Problem; Defective Device; Signal Artifact/Noise; Pacing Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAS A NOISE ON THE RV CHANNEL THAT INHIBITED PACING DUE TO BROKEN LEAD. IN ADDITION, PRIOR RV LEAD EXTRACTION, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO LOW BLOOD PRESSURE, FATIGUE, LIGHTHEADEDNESS, AND DIZZINESS. THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Fatigue; Low Blood Pressure/ Hypotension

  MAUDE report 19621225 ↗
• MalfunctionJun 26, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED NOISE AT THE BEGINNING OF A MEDIATED TACHYCARDIA (PMT) EPISODE WHICH CAUSE PACING INHIBITION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED PMT APPEARED TO BE SINUS TACH AT MAXIMUM TRACKING RATE (MTR). ISOMETRICS AND POCKET MANIPULATION TESTING WAS PERFORMED WHICH DID NOT REPRODUCE THE NOISE ON THE RV RATE/SENSE. THE PATIENT TOOK DEEP BREATHS, AND SOME NOISE WAS VISIBLE ON THE RATE/SENSE. TS NOTED THE NOISE APPEARED TO BE DIAPHRAGMATIC NOISE AND NOT LEAD INTEGRITY. RV MEASUREMENTS REMAIN STABLE AND WITHIN NORMAL LIMITS. TS CONFIRMED THE LIMITED PRESENCE OF OVERSENSED NOISE BUT NOT FOR LONG PERIODS AND RECOMMENDED INCREASING THE RV SENSING MEASUREMENTS OR LEAVE IT AS IT IS. THIS LEAD REMAINS IN SERVICE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 19615914 ↗
• InjuryJun 18, 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 SYSTEM REVISION DUE TO BACTEREMIA. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 19564162 ↗
• InjuryApr 22, 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 SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19159958 ↗
• InjuryFeb 8, 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 SYSTEM REVISION DUE TO INFECTION AND SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18672376 ↗
• InjuryDec 6, 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 18275767 ↗
• InjurySep 1, 2023Signal 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 LEAD EXHIBITED NOISE, OVERSENSING AND PACING INHIBITION OF UP TO SEVEN SECONDS. DUE TO THIS, INAPPROPRIATE EPISODES WERE STORED. ADDITIONALLY, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE NOTED. FURTHER EVALUATION OF THE PATIENT WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 17669863 ↗
• InjuryAug 24, 2023Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD 4 VOLTS AT 2 POST MAGNETIC RESONANCE IMAGING (MRI). A SCHEDULED OF LEAD EXTRACTION WAS PLANNED OUT. SUBSEQUENTLY, THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THE SUSPECTED CAUSED WAS DUE TO MICRO DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613436 ↗
• InjuryAug 22, 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17599917 ↗
• InjuryAug 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS BEEN DISLODGED SHORTLY AFTER IMPLANT AND WAS DETECTED THROUGH X-RAY PRIOR TO DISCHARGE. THIS LEAD REMAINED IN THE VENTRICLE, BUT THE COIL WAS NO LONGER AN OPTIMAL POSITION, AND THE LEAD WAS NOT STABLE. THE PHYSICIAN DID RV LEAD REVISION ON THE SAME DATE AND SUCCESSFULLY REPOSITIONED THE ORIGINAL LEAD. THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503291 ↗
• InjuryAug 10, 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 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 17501884 ↗

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-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