ENDOTAK RELIANCE® SG 0283Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00802526431388), received between Oct 13, 2016 and Jun 2, 2026 — classified as 1 death, 23 injuries, 25 malfunctions.

The most frequently reported specific device problem is “High impedance” (24 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUAL RISE OF THE SHOCK IMPEDANCE MEASUREMENTS. REPROGRAMMING EFFORTS WERE PERFORMED. CURRENTLY, THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368531 ↗
• MalfunctionMar 30, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM RECORDED A RED DOCTOR ICON DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND RECOMMENDED FOLLOW UP WITH THE CLINIC. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737393 ↗
• MalfunctionFeb 4, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND A GRADUAL INCREASE IN HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 2000 OHMS. TECHNICAL SERVICES (TS) NOTED THERE WAS A CHANGE IN THE TIP TISSUE INTERFACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259758 ↗
• InjuryAug 13, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE ACCIDENTALLY DAMAGED. THE PHYSICIAN OPTED TO REMOVE THE DAMAGED LEADS AND REPLACED THEM WITH NEW LEADS SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RA AND RV LEADS WERE RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800487 ↗
• InjuryAug 4, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS SUSPECTEDLY DUE TO EXIT BLOCK. THIS RV LEAD WAS EXPLANTED, REPLACED AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709275 ↗
• MalfunctionJul 30, 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 22666146 ↗
• InjuryMar 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 INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21665243 ↗
• MalfunctionFeb 6, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS DISCUSSED OPTIONS. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327334 ↗
• MalfunctionJan 27, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON THE PRESENTING ELECTROGRAM. THE HEALTH CARE PROFESSIONAL ADVISED THE PATIENT WOULD BE SEEN IN CLINIC FOR TROUBLESHOOTING. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THE PATIENT WAS SUBSEQUENTLY SEEN IN CLINIC. SENSITIVITY WAS REPROGRAMMED. NO OVERSENSING HAS BEEN OBSERVED FOLLOWING THE PROGRAMMING CHANGE. THE PATIENT CONTINUES TO BE MONITORED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241423 ↗
• MalfunctionJun 18, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS THAT WERE UP TO 128 OHMS. TECHNICAL SERVICES (TS) NOTED THAT THESE MEASUREMENTS HAD BEEN VARIABLE OVER THE PAST YEAR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556938 ↗
• DeathMay 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 ASSOCIATED WITH A SYSTEM INFECTION. SURGICAL INTERVENTION WAS PERFORMED. AND THE RV LEAD WAS EXPLANTED. THE PATIENT, DEVELOPED A PERICARDIAL EFFUSION, AFTER THE PROCEDURE. AND EXPERIENCED CARDIAC TAMPONADE. AND LATER PASSED AWAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19274052 ↗
• InjuryMar 21, 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. REPORTEDLY, THE PATIENT FELL AND HIT THE IMPLANTED DEVICE, WHICH CAUSED SWELLING AND WAS SENSITIVE. THE PATIENT WAS IN PAIN AND FELT THE WIRES TO THE DEVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Fall; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18953755 ↗
• InjuryMar 20, 2024High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947261 ↗
• InjuryOct 19, 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 17971486 ↗
• MalfunctionSep 22, 2023Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY RISING PACING IMPEDANCE VALUES, HIGH CAPTURE THRESHOLDS, AND INTERMITTENT CAPTURE. REPROGRAMMING WAS PERFORMED. THE PATIENT WILL BE CONTINUED TO BE MONITORED. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798802 ↗
• MalfunctionSep 7, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND REPROGRAMMING OPTIONS WERE RECOMMENDED. 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 17700638 ↗
• MalfunctionAug 11, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT A DEVICE CHECK OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM REVEALED A GRADUAL INCREASE IN RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCE MEASUREMENTS OVER THE LAST FIVE YEARS FROM 1,300 OHMS TO 2,286 OHMS AND SIGNAL ARTIFACT MONITORING (SAM) DISABLED THE RESPIRATORY RATE TREND (RRT) FEATURE. ADDITIONALLY, THRESHOLD MEASUREMENTS HAD INCREASED TO 3.1V@MS AND PACING OUTPUTS WERE INCREASED. NO OVERSENSING WAS NOTED, AND THE PATIENT IS NOT PACER DEPENDENT. THIS ICD SYSTEM REMAINS IN SERVICE AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514595 ↗
• MalfunctionJun 20, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD PACING LEAD IMPEDANCE MEASUREMENT MEASUREMENTS THAT WERE GREATER THAN 2100 OHMS, WHICH WAS OUT-OF-RANGE. TECHNICAL SERVICES (TS) ANALYZED THE PRESENTING ELECTROGRAM (EGM) AND FOUND THAT THE IMPEDANCE MEASUREMENTS HAD BEEN GRADUALLY RISING AND THE THRESHOLD WERE AT 3.1V. TS RECOMMENDED REPROGRAMMING OPTIONS AS TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161968 ↗
• MalfunctionMay 11, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN PACE IMPEDANCE MEASUREMENTS, CLIMBING GREATER THAN 2,000 OHMS. NO NOISE WAS OBSERVED AND THE INTRINSIC AMPLITUDE, THRESHOLD AND SHOCK IMPEDANCE MEASUREMENTS WERE STABLE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING AND OR MONITORING WITH THE HEALTH CARE PROFESSIONAL (HCP). THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910794 ↗
• InjurySep 19, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK IMPEDANCE, RISING SINCE NOVEMBER 2021 FROM 125 OHMS TO 175 OHMS. IN 2019, DEVICE DELIVERED SHOCK THERAPY AND SHOCK IMPEDANCE WAS AT 65 OHMS. RV PACING IMPEDANCE INCREASED FROM 800 OHMS ( AT IMPLANT) TO 1700 OHMS. RV PACING THRESHOLD WHERE 0.5MS X 0.5MS (AT IMPLANT) TO 2.7MS X 1.0MS REPORTED TODAY. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT OVER THE HOME MONITORING SYSTEM. THE RV LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock

  MAUDE report 15447203 ↗
• InjuryJun 20, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. A NEW RV WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. INFORMATION FROM THE FIELD INDICATED THIS LEAD WAS EXPLANTED DUE TO NOISE. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749156 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INFECTION AND WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14721555 ↗
• MalfunctionJun 6, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) SHOCK LEAD WAS EXHIBITING LOSS OF CAPTURE DUE TO LEAD DISLODGEMENT. THE REPRESENTATIVE TESTED THE LEAD AND CONFIRMED THE LOSS OF CAPTURE. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606115 ↗
• InjuryJan 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A GRADUAL INCREASE OF HIGH SHOCK IMPEDANCE MEASUREMENTS IN THE RIGHT VENTRICULAR (RV) LEAD OVER THE PAST YEAR. DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR THEIR REVIEW AND RECOMMENDATIONS. DATA WAS REVIEWED AND TROUBLESHOOTING WAS RECOMMENDED BY TS. PHYSICIAN DECIDED TO SCHEDULE A NEW FOLLOW UP. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 13228488 ↗
• MalfunctionJan 11, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES MEASURING 2089 OHMS. ADDITIONALLY, IT WAS NOTED THAT THRESHOLDS HAVE INCREASED. TECHNICAL SERVICES RECOMMENDED TO REVIEW TRENDS OVER THE LAST YEAR. AT THIS TIME, THE HEALTH CARE PROFESSIONAL (HCP) WILL CONTINUE TO MONITOR. THE PATIENT IS NOT DEPENDENT ON THERAPY. 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 13226743 ↗

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-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