ENDOTAK RELIANCE SRecalls & reported problems across all models

We found 7 models of ENDOTAK RELIANCE S by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,133 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Sep 30, 2026 — classified as 5 deaths, 846 injuries, 282 malfunctions.

The most frequently reported specific device problem is “High impedance” (198 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 S problems

ENDOTAK RELIANCE S models

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

• ENDOTAK RELIANCE® S 640272-103

  Permanent defibrillator electrodes
  3 deaths516 reports
• ENDOTAK RELIANCE® S 640273-103

  Permanent defibrillator electrodes
  2 deaths391 reports
• ENDOTAK RELIANCE® S 0138

  Implantable cardioverter defibrillator (non-CRT)
  116 reports
• ENDOTAK RELIANCE® S 0137

  Implantable cardioverter defibrillator (non-CRT)
  59 reports
• ENDOTAK RELIANCE® S 640262-103

  Permanent defibrillator electrodes
  27 reports
• ENDOTAK RELIANCE® S 640263-103

  Permanent defibrillator electrodes
  15 reports
• ENDOTAK RELIANCE® S 0128

  Implantable cardioverter defibrillator (non-CRT)
  9 reports

Recent ENDOTAK RELIANCE S adverse event reports

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

• MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) had an episode of pacemaker mediated tachycardia (PMT). Technical Services (TS) was consulted and reviewed stored data. TS noted there was an isolated instance of oversensing of noisy signals for its right ventricular (RV) lead. TS discussed troubleshooting options and recommended further in clinic examination. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947729 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  It was reported that this brady lead was an attempted implant due to unknown product performance anomaly. A new lead with the same model was implanted. No adverse patient effects were reported. The lead was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943680 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this previously capped implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The previously capped implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50942454 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited an unknown product performance anomaly. A revision procedure was performed. This RV lead was surgically abandoned and replaced with a new lead successfully. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927562 ↗
• InjurySep 28, 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 50919653 ↗
• InjurySep 23, 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 50872730 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was surgically abandoned due to unknown reasons. This RV lead was successfully replaced and no additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789024 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736139 ↗
• InjurySep 11, 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 50734241 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50368214 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Material Integrity Problem

  It was reported that the implantable cardioverter defibrillator (ICD) and this right ventricular (RV) lead delivered inappropriate anti-tachycardia pacing (ATP) and a single shock due to oversensing of noise. The patient had a strong underlying rhythm, and no pacing inhibition was noted. The field representative (rep) didn't know what the patient was doing when the noise was recorded. Technical Services (TS) discussed troubleshooting options to reproduce the noise and recommended asking what the patient was doing at the time of the shock. This RV lead remains in service. No adverse patient effects were reported.Additional information was received from the field. The patient was seen in clinic and the physician suspected subclavian crush. The ICD was explanted and replaced. This RV lead was surgically abandoned and replaced. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50326257 ↗
• InjuryAug 17, 2026Device Sensing Problem; Device Dislodged or Dislocated

  It was reported that the patient with this right ventricular (RV) lead underwent a surgical intervention to reposition the lead as sensing had decreased possibly due to a microdislodgement. The RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287269 ↗
• InjuryAug 14, 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 was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50263475 ↗
• InjuryAug 11, 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 Methicillin-resistant Staphylococcus aureus (MRSA) infection. There was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Bacterial Infection

  MAUDE report 50209667 ↗
• InjuryAug 11, 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 50207594 ↗

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