ENDOTAK RELIANCE® G 0187Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00802526531217), received between Nov 7, 2016 and Nov 21, 2022 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High impedance” (5 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-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING THE NON BOSTON SCIENTIFIC DEVICE EXPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND EXHIBITING HIGH SHOCK IMPEDANCES OUT OF RANGE. TECHNICAL SERVICES (TS) RECOMMENDED TO PERFORM A DEFIBRILLATION THRESHOLD (DFT) TEST, NONETHELESS, THE PHYSICIAN DECIDED TO NOT PERFORM IT. A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED AND CONNECTED TO THIS RV LEAD. THE RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 15839527 ↗
• MalfunctionMay 27, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING REPLACEMENT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THE SHOCK IMPEDANCE OF THE PROXIMAL COIL OF THE RIGHT VENTRICULAR LEAD AS GREATER THAN 200 OHMS. THE PHYSICIAN ELECTED TO PROGRAM A SINGLE COIL CONFIGURATION USING THE DISTAL COIL THAT HAD NORMAL IMPEDANCE OF 85 OHMS. THE RV LEAD REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14529257 ↗
• InjuryNov 2, 2021Adverse 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE DEVICE WAS SENT TO HISTOLOGY DEPARTMENT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 12735596 ↗
• InjuryJul 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND OUT TO BE DISLODGED. THE LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10226427 ↗
• MalfunctionApr 12, 2019High impedance; Off-Label Use; High impedance; Off-Label Use

  IT WAS REPORTED THAT DURING THE DEVICE REPLACEMENT PROCEDURE WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HIGH OUT OF RANGE SHOCK IMPEDANCES MEASURING GREATER THAN 125 OHMS WERE EXHIBITED. WHEN THE SHOCK LEAD VECTOR WAS PROGRAMMED DISTAL COIL TO CAN THE IMPEDANCES WERE OUT OF RANGE. THE PROXIMAL TERMINAL PIN WAS CONNECTED TO THE DISTAL PORT AND THE DISTAL TERMINAL PIN WAS CONNECTED TO THE PROXIMAL PORT. WHEN THE LEADS WERE REVERSED IN THE HEADER THE SHOCK IMPEDANCES WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED SINCE THE DEVICE IS IMPLANTED IN THE ABDOMEN THIS MAY BE A WORKABLE VECTOR, HOWEVER, THEY RECOMMENDED PERFORMING DEFIBRILLATION THRESHOLD (DFT) TESTING TO CONFIRM. SUBSEQUENTLY, DFT TESTING WAS PERFORMED AND THE PATIENT'S RHYTHM WAS SUCCESSFULLY CONVERTED. THIS ICD WAS SUCCESSFULLY IMPLANTED AND REMAINS IN SERVICE. THE RV LEAD ALSO REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8510860 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8314734 ↗
• InjuryOct 24, 2018High impedance; Over-Sensing; Device Sensing Problem; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE OF GREATER THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED BRINGING THE PATIENT INTO THE CLINIC FOR FURTHER EVALUATION INCLUDING ISOMETRICS. THIS PRODUCT REMAINS IN SERVICE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8002688 ↗
• MalfunctionNov 7, 2016High impedance; High impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD AND ANOTHER MANUFACTURE'S DEVICE DISPLAYED HIGH SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES DIRECTED THE CALLER TO THE DEVICE MANUFACTURE'S TECHNICAL SERVICES. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE DID NOT HAVE ANY FURTHER INFORMATION. THE LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6082433 ↗

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-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,