ENDOTAK RELIANCE GRecalls & reported problems across all models

We found 12 models of ENDOTAK RELIANCE G by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 5,053 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2013 and Sep 29, 2026 — classified as 36 deaths, 3,492 injuries, 1,525 malfunctions.

The most frequently reported specific device problem is “High impedance” (2,381 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 G 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 4 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 5 of these models · Recall details · FDA record ↗

Most reported ENDOTAK RELIANCE G problems

ENDOTAK RELIANCE G models

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

• ENDOTAK RELIANCE® G 0185

  Implantable cardioverter defibrillator (non-CRT)
  9 deaths1,632 reports
• ENDOTAK RELIANCE® G 0295

  Permanent defibrillator electrodes
  1 recall9 deaths1,070 reports
• ENDOTAK RELIANCE® G 0296

  Permanent defibrillator electrodes
  1 recall4 deaths862 reports
• ENDOTAK RELIANCE® G 0184

  Implantable cardioverter defibrillator (non-CRT)
  7 deaths838 reports
• ENDOTAK RELIANCE® G 0175

  Implantable cardioverter defibrillator (non-CRT)
  1 recall5 deaths314 reports
• ENDOTAK RELIANCE® G 0174

  Implantable cardioverter defibrillator (non-CRT)
  1 recall112 reports
• ENDOTAK RELIANCE® G 0285

  Permanent defibrillator electrodes
  1 recall1 death92 reports
• ENDOTAK RELIANCE® G 0286

  Permanent defibrillator electrodes
  1 recall83 reports
• ENDOTAK RELIANCE® G 0187

  Implantable cardioverter defibrillator (non-CRT)
  1 recall8 reports
• ENDOTAK RELIANCE® G 0176

  Implantable cardioverter defibrillator (non-CRT)
  1 recall2 reports
• ENDOTAK RELIANCE® G 0177

  Implantable cardioverter defibrillator (non-CRT)
  1 recall0 reports
• ENDOTAK RELIANCE® G 0186

  Implantable cardioverter defibrillator (non-CRT)
  1 death40 reports

Recent ENDOTAK RELIANCE G adverse event reports

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

• InjurySep 29, 2026High Capture Threshold

  It was reported that prior to a gen change, this right ventricular (RV) lead exhibited a high capture threshold. The physician opted to cap the lead and implant a new RV lead. The lead was successfully implanted, and no additional adverse patient effects were reported. This RV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935441 ↗
• MalfunctionSep 29, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements. Technical Services (TS) was consulted and confirmed out of range measurements. TS noted that the system was reprogramming to a different vector with measurements that were within range. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933493 ↗
• MalfunctionSep 28, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited shock impedance measurements that were high and out of range. Technical Services (TS) was consulted, and it was noted that the patient subsequently underwent a device replacement procedure due to normal battery depletion (NBD). During the procedure, the physician elected not to replace the RV lead despite the out of range shock impedance measurements. The local company representative discussed the lead findings and associated risks with the physician. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911020 ↗
• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902958 ↗
• InjurySep 24, 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. No additional adverse patient effects were reported. This lead remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882479 ↗
• MalfunctionSep 23, 2026Failure to Capture; High impedance; High Capture Threshold

  It was reported that this right ventricular (RV) lead is exhibiting highly variable and intermittently high threshold measurements as well as gradually rising pace impedance measurements that are within normal specification limits. Boston Scientific Technical Services (TS) reviewed device electrograms and lead trend data. TS indicated manual RV capture tests performed in the clinic were appropriate and noted it is odd that pacing output has been up to 7.5 Volts to get capture at one point but have come back down. TS stated this as well as the gradual increase in pace impedance measurement are less indicative of a lead fracture and more related to the lead-tissue interface. TS also noted that since the patient was indicated to have frequent ablations, this could also be contributing to changes in the heart tissue near the lead helix. TS indicated that the patient has nearly no stored episodes and nothing to suggest a lead fracture. TS provided guidance to the physician that since there is good left ventricular capture, it seems reasonable to monitor the RV lead for now. The RV lead remains in-service. No patient symptoms or adverse patient effects were reported.Additional informatio

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871533 ↗
• MalfunctionSep 18, 2026High impedance; Failure to Convert Rhythm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829979 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829439 ↗
• MalfunctionSep 18, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) system experienced a non-sustained ventricular tachycardia (NSVT) episode which appeared to have a pattern of oversensed non physiologic noise in the right ventricular (RV) channel. Technical Services (TS) was contacted and recommended following up. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817919 ↗
• InjurySep 15, 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 50774396 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695669 ↗
• MalfunctionSep 9, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements due to a system Code 1005. Technical Services (TS) was consulted and recommended clearing the Code 1005 and further evaluating the system. TS noted that a shock was appropriately delivered to the patient. TS recommended considering lead replacement due to the system Code. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688599 ↗
• InjurySep 7, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658535 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602356 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602322 ↗

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