ENDOTAK RELIANCE® G 0295Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,070 adverse event reports that list this exact device (DI 00802526531262), received between Jul 1, 2015 and Sep 29, 2026 — classified as 9 deaths, 778 injuries, 283 malfunctions.

The most frequently reported specific device problem is “High impedance” (369 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-2326-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,070 reports, 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 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 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, 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 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 ↗
• MalfunctionSep 4, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600834 ↗
• InjurySep 3, 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 50586931 ↗
• InjuryAug 24, 2026High impedance

  It was reported that this right ventricular (RV) defibrillation lead was surgically abandoned and replaced due to a gradual rise in shock impedances to out-of-range measurements greater than 125 Ohms. It was noted that the lead revision occurred during the routine battery replacement procedure. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50415978 ↗
• InjuryAug 20, 2026Impedance Problem

  It was reported that this right ventricular (RV) lead was surgically abandoned during a device replacement procedure. The device was replaced due to reaching Elective Replacement Indicator (ERI). The physician chose to implant a new RV lead instead of using this RV lead due to inconsistent impedance measurements. The physician suspected that trying to remove or using this RV lead with the new implant would cause damage. This RV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354635 ↗
• InjuryAug 19, 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 50326200 ↗
• InjuryAug 17, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited shock impedance measurements high out of range. Subsequently, this lead was explanted and replaced. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288798 ↗
• InjuryAug 14, 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 50261994 ↗
• MalfunctionAug 12, 2026Failure to Capture; High impedance; High Capture Threshold

  It was reported that this right ventricular (RV) lead recorded a gradual rise in pacing impedance measurements within normal limits and no capture at maximum output. Technical Services (TS) reviewed the device data and provided reprogramming options to this system, considering the left ventricular (LV) lead is located on left bundle branch (LBB). The plan is to continue monitoring and consider lead replacement if necessary. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229860 ↗
• InjuryAug 6, 2026Material Integrity Problem

  It was reported this right ventricular (RV) lead was surgically abandoned due to inadvertently cut above the coil during a procedure, leaving the lead tip retained in the tissue. No additional adverse patient effects were reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50161987 ↗
• MalfunctionAug 6, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160774 ↗
• MalfunctionAug 5, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150250 ↗
• MalfunctionAug 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134909 ↗
• InjuryJul 30, 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 50087885 ↗
• MalfunctionJul 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894293 ↗
• InjuryJul 8, 2026High impedance; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD A VENTRICULAR TACHYCARDIA (VT) THAT WAS UNABLE TO BE CONVERTED BY THERAPY DELIVERY, WITH ALL THERAPY EXHAUSTED. ADDITIONALLY, DURING THE VT EPISODE THERE WAS A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT AND A FC1005 CODE WAS DISPLAYED BY THE DEVICE DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH TS NOTING THE SHOCK IMPEDANCE INCREASED GRADUALLY. TS RECOMMENDED REPLACING THE RIGHT VENTRICULAR (RV) LEAD. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25757533 ↗
• MalfunctionJun 24, 2026Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE MEASUREMENTS. THE PATIENT HAS A NON BOSTON SCIENTIFIC IMPLANTABLE DEVICE. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER EVALUATION. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610803 ↗
• InjuryJun 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 25595525 ↗

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-2325-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o18
• 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,