ENDOTAK RELIANCERecalls & reported problems across all models

We found 8 models of ENDOTAK RELIANCE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 993 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2009 and Sep 28, 2026 — classified as 9 deaths, 758 injuries, 226 malfunctions.

The most frequently reported specific device problem is “High impedance” (286 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ENDOTAK RELIANCE problems

ENDOTAK RELIANCE models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENDOTAK RELIANCE® 0158

  Implantable cardioverter defibrillator (non-CRT)
  1 death331 reports
• ENDOTAK RELIANCE® 0148

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths223 reports
• ENDOTAK RELIANCE® 0157

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths165 reports
• ENDOTAK RELIANCE® 0275

  Permanent defibrillator electrodes
  90 reports
• ENDOTAK RELIANCE® 0147

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths78 reports
• ENDOTAK RELIANCE® 0276

  Permanent defibrillator electrodes
  2 deaths74 reports
• ENDOTAK RELIANCE® 0266

  Permanent defibrillator electrodes
  24 reports
• ENDOTAK RELIANCE® 0265

  Permanent defibrillator electrodes
  8 reports

Recent ENDOTAK RELIANCE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Over-Sensing; Pacing Problem; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926081 ↗
• MalfunctionSep 26, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906402 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50902892 ↗
• MalfunctionSep 22, 2026High impedance

  Boston Scientific CRM received information that this Right Ventricular (RV) defibrillation lead exhibited high pace impedance >2000 ohms. Impedance had been rising from approximately 1800 ohms in November to >2000 ohms now. No adverse patient effects have been reported. Additional information indicated that the lead continues to have high pacing impedance measurements. The physician is aware of these measurements and has decided to monitor the patient at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862154 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698454 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696282 ↗
• MalfunctionSep 4, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602230 ↗
• 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 ↗
• MalfunctionAug 7, 2026High impedance

  It was reported that this right ventricular (RV) lead triggered an alert for high, out of range shock impedance values. After a vector breakdown a proximal coil issue was identified. Technical Services (TS) mentioned that if the plan was to reprogram for changing shocking vectors, then a defibrillation threshold (DFT) test should be completed.Additional information from the field was received mentioning that the origin for the high, out of range shock impedance was confirmed to be an issue at the proximal coil by doing a vector breakdown. Also, the lead was reprogramed distal coil to device, and a defibrillation threshold test was completed. The RV lead remains in service at this time. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169672 ↗
• MalfunctionJul 27, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008149 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND SEPSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25676737 ↗
• InjuryJun 9, 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 EROSION AND INFECTION. THE PATIENT EXPERIENCED EDEMA, INFLAMMATION AND SWELLING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS CUT FROM THE TERMINAL PIN, AND THE LEAD BODY REMAINS IMPLANTED AND INACTIVE.

  Patient problems: Erosion; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25446911 ↗
• MalfunctionMay 15, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH WAS OVERSENSED. TECHNICAL SERVICES (TS) SUSPECTED THE NOISE WAS ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS ALSO REPORTED THIS RV LEAD EXHIBITED A GRADUAL RISE OF PACING IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. TS RECOMMENDED CONTINUED MONITORING. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186118 ↗
• 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 ↗

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