ENDOTAK RELIANCE® SG 0282Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00802526431371), received between Jul 16, 2016 and May 29, 2026 — classified as 57 injuries, 38 malfunctions.

The most frequently reported specific device problem is “High impedance” (50 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Jul 24, 2025Class IOpen, Classified

   Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

   Z-2326-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026High impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW REPORTS FOR THIS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND DETERMINED THAT THIS RV LEAD EXHIBITED EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PLAN IS TO CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340307 ↗
• MalfunctionApr 20, 2026Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED ADJUSTING SENSING AND PERFORMING A DEFIBRILLATION THRESHOLD (DFT) TEST. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926998 ↗
• InjuryApr 17, 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 POSSIBLE INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 24909699 ↗
• MalfunctionJan 26, 2026High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF 137 OHMS. THE PATIENT HAS A NON-BOSTON SCIENTIFIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THEREFORE, TECHNICAL SERVICES (TS) RECOMMENDED THE HEALTH CARE PROFESSIONAL (HCP) FOLLOW-UP WITH THE ICD MANUFACTURER FOR RECOMMENDATIONS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183503 ↗
• InjuryJan 2, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. TECHNICAL SERVICES (TS) ADVISED THE PATIENT APPEARS TO BE ATRIAL DEPENDENT. TS PROVIDED TROUBLESHOOTING SUGGESTIONS. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED TO THEIR KNOWLEDGE NO MAGNETIC RESONANCE IMAGING HAS BEEN PERFORMED AT THIS TIME. SUBSEQUENTLY, THIS RV LEAD WAS SURGICALLY ABANDONED. ANOTHER RV LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944002 ↗
• InjuryDec 23, 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 23878693 ↗
• InjuryNov 4, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE GRADUAL RISING PACING IMPEDANCES. IT WAS ALSO NOTED THAT THERE WERE GRADUAL RISING SHOCK IMPEDANCES WITHIN NORMAL LIMITS AND NOISY SIGNALS. TECHNICAL SERVICES (TS) RECOMMENDED TO HAVE A LEAD REVISION. TACHY THERAPY WAS STATED TO BE TURNED OFF FOR THIS PATIENT. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460835 ↗
• MalfunctionSep 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER 125 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED THAT GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS WAS NOTED. TS RECOMMENDED SETTING A HIGHER OUT OF RANGE LIMIT. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965322 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649228 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649220 ↗
• InjuryJul 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22543625 ↗
• MalfunctionJul 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22442426 ↗
• InjuryJun 13, 2025Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO EXHIBITING IMPEDANCE ISSUES AND HIGH PACING THRESHOLDS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205265 ↗
• InjuryMar 7, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD FRACTURE. THIS RV LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551009 ↗
• InjuryJan 8, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO A PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102822 ↗
• InjuryNov 19, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS TROUBLESHOOTING OPTIONS FOR FURTHER EXAMINATION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FILED INDICATES A COMMANDED SHOCK AND A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED DURING THE SCHEDULED PULSE GENERATOR CHANGEOUT, WITH THE SHOCK IMPEDANCE MEASUREMENTS WITHIN ESTABLISHED LIMITS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724186 ↗
• MalfunctionOct 17, 2024Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT FOLLOWING A ROUTINE DEVICE CHANGEOUT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-CAPTURE. THE NEWLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO LEFT VENTRICULAR (LV) ONLY PACING AND ANTI-TACHYCARDIA PACING (ATP) WAS PROGRAMMED OFF. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD EXHIBITED LOSS OF CAPTURE (LOC) SINCE 2021 AND ANTI-TACHYCARDIA PACING (ATP) HAD BEEN PROGRAMMED OFF AT THAT TIME. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471287 ↗
• InjuryAug 14, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19986182 ↗
• InjuryJul 3, 2024High impedance; Over-Sensing; Pacing Problem; High Capture Threshold; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND HIGH CAPTURE THRESHOLDS. THE PHYSICIAN DECIDED TO HAVE TACHY SET TO MONITOR ONLY SO NO INAPPROPRIATE THERAPY OCCURRED AND ALSO WAS PROGRAMMED DUE TO OVERSENSING AND PACING INHIBITION ON THE RV. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE RV WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE REACHED ELECTIVE REPLACEMENT TIME (ERT) AND WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 19671498 ↗
• InjuryMay 20, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS, GRADUAL RISE OF SHOCK AND PACING IMPEDANCES. IT WAS NOTED THAT THE SHOCK IMPEDANCES WERE HIGH OUT OF RANGE MEASURING GREATER THAN 125 OHMS AND THE PACING IMPEDANCES WHERE HIGH WITHIN NORMAL LIMITS. FLUOROSCOPY WAS PERFORMED AND NO EVIDENCE OF LEAD FRACTURE OR LEAD INTEGRITY WAS OBSERVED. THE PHYSICIAN BELIEVES THAT THE GRADUAL RISE IN SHOCK AND PACING IMPEDANCES MAY HAVE BEEN DUE TO CALCIUM BUILD UP ON THE LEAD. A LEAD REVISION PROCEDURE WAS PERFORMED, THIS RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 19353071 ↗
• MalfunctionApr 29, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXHIBITING RIGHT VENTRICULAR (RV) LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) RECOMMENDED EVALUATING THRESHOLDS IN THE CLINIC. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203284 ↗
• InjuryApr 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012032 ↗
• MalfunctionMar 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES. THERE WAS NO NOISE OBSERVED. TECHNICAL SERVICES (TS) RECOMMENDED FOR A COMMANDED SHOCK TEST TO BE PERFORMED TO FURTHER EVALUATE THE LEAD INTEGRITY. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984017 ↗
• MalfunctionFeb 12, 2024High impedance; High impedance

  IT WAS REPORTED BY THE PATIENT THAT THE COMMUNICATOR SHOWED A RED CALL DOCTOR (RCD) ICON WHILE TRYING TO COMMUNICATE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). LATITUDE REPORTS REVEAL THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE FOR SEVERAL YEARS. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THE CLINIC. NO INTERVENTIONS ARE PLANNED AT THIS MOMENT. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686064 ↗
• InjuryOct 13, 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. REPORTEDLY, ESCHERICHIA COLI WAS FOUND ON THE LEAD, WHICH WAS SUSPECTED THAT CAME FROM THE URINARY TRACT INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 17935998 ↗

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,