ENDOTAK RELIANCE SGRecalls & reported problems across all models

We found 9 models of ENDOTAK RELIANCE SG by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 6,540 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2013 and Sep 30, 2026 — classified as 30 deaths, 4,068 injuries, 2,442 malfunctions.

The most frequently reported specific device problem is “High impedance” (3,130 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

ENDOTAK RELIANCE SG recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 24, 2025Open, 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 · names 2 of these models · Recall details · FDA record ↗

2. Jul 24, 2025Open, 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 · names 2 of these models · Recall details · FDA record ↗

Most reported ENDOTAK RELIANCE SG problems

ENDOTAK RELIANCE SG models

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

• ENDOTAK RELIANCE® SG 0292

  Permanent defibrillator electrodes
  16 deaths3,197 reports
• ENDOTAK RELIANCE® SG 0293

  Permanent defibrillator electrodes
  8 deaths2,039 reports
• ENDOTAK RELIANCE® SG 0181

  Implantable cardioverter defibrillator (non-CRT)
  3 deaths651 reports
• ENDOTAK RELIANCE® SG 0180

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths436 reports
• ENDOTAK RELIANCE® SG 0282

  Permanent defibrillator electrodes
  1 recall95 reports
• ENDOTAK RELIANCE® SG 0283

  Permanent defibrillator electrodes
  1 recall1 death49 reports
• ENDOTAK RELIANCE® SG 0171

  Implantable cardioverter defibrillator (non-CRT)
  1 recall41 reports
• ENDOTAK RELIANCE® SG 0170

  Implantable cardioverter defibrillator (non-CRT)
  1 recall19 reports
• ENDOTAK RELIANCE® SG 0182

  Implantable cardioverter defibrillator (non-CRT)
  13 reports

Recent ENDOTAK RELIANCE SG adverse event reports

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

• MalfunctionSep 30, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shocking lead impedances. The shock impedances were noted to be gradually rising. The rep was looking for recommendations for potential changeout. Technical Services (TS) recommended monitoring the lead. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946748 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  It was reported that this lead was surgically abandoned due to unknown reasons. Additional information was requested but unable to be obtained at this time. This lead was successfully replaced, and no additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946687 ↗
• InjurySep 30, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946352 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938831 ↗
• MalfunctionSep 29, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high out of range shock impedance measurements greater than 125 Ohms. Technical Services (TS) was contacted and observed that it could be something physiological. TS also recommended follow up and possible reprogramming options. This right ventricular (RV) lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927641 ↗
• MalfunctionSep 28, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited a gradual rise to out of range shock impedance measurements. Technical Services (TS) recommended bringing the patient into the clinic to clear the alert and increase the alert value to 150 ohms. TS also recommended continued monitoring for the patient. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916732 ↗
• MalfunctionSep 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890351 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted due to an unknown product performance issue. This RV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872465 ↗
• InjurySep 23, 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 50865765 ↗
• InjurySep 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 infection. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50801745 ↗
• MalfunctionSep 17, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) and right ventricular (RV) lead recorded a shock lead impedance of 10 ohms during a hospital check. Technical Services (TS) was consulted and noted this was likely due to electromagnetic interference (EMI) given the hospital environment. It was noted that the local company representative repeated the test and a measurement of 90 ohms was obtained. No further out of range measurements were noted. This ICD and RV lead remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797673 ↗
• InjurySep 16, 2026Signal Artifact/Noise; Off-Label Use

  It was reported that this right ventricular (RV) lead exhibited noise on the shock channel that was not oversensed. Technical Services (TS) recommended continuous monitoring. This lead remains in service. No adverse patient effects were reported.Additionally, it was noted that the patient was prepped to undergo a non-conditional magnetic resonance imaging (MRI). This lead remains in service. No adverse patient effects were reported.Subsequently, additional information received reported that this right ventricular (RV) lead was explanted and replaced with a new lead. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789260 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. Reportedly, the patient had a Coronary Artery Bypass Grafting (CABG) and the ejection fraction (EF) had improved. Subsequently, the patient had a blood clot with sepsis anomaly. Furthermore, the patient recovered to the procedures but now had the atrial flutter (AF) with decreased EF. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Atrial Flutter; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50784991 ↗
• InjurySep 15, 2026Data Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) for assistance with programming this implantable cardioverter defibrillator (ICD) system into magnetic resonance imaging (MRI) protection mode. TS confirmed this ICD system was MRI conditional and assisted with programming. The MRI was successfully completed, and TS confirmed the device was functioning as programmed after the MRI and that all measurements were within range. It was noted that the medical records showed that the right ventricular (RV) lead was explanted. However, there was confirmation that the lead was repositioned and still in use. It was not determined why the lead was repositioned. An email was sent to medical records to update the information. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779379 ↗
• MalfunctionSep 14, 2026High impedance

  It was reported that this right ventricular (RV) lead triggered an alert for high, out of range Shock Impedance (LVSI) showing a gradual increase. It was discussed that the lead would require replacement when 30 day average becomes 150 ohms or greater. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754375 ↗

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