ENDOTAK RELIANCE® SG 0293Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,039 adverse event reports that list this exact device (DI 00802526531255), received between Jul 9, 2013 and Sep 30, 2026 — classified as 8 deaths, 1,327 injuries, 704 malfunctions.

The most frequently reported specific device problem is “High impedance” (857 reports).

3 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,039 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  It was reported that electrogram (EGM) review was requested due to right ventricular (RV) lead noise on the presenting. The noise was not oversensed in the stored event, and the noise was not reproducible with arm movements or pocket manipulation. The noise was erratic and measured at 0.7 mV. Upon review, the noise appeared consistent with myopotential, and was rhythmic. Daily intrinsic amplitudes suggest the noise was likely oversensed, as daily measurements were around 0.1 mV frequently. Additionally, RV pace impedances had decreased from 900 Ohms at implant to 460 Ohms. Technical Services (TS) discussed troubleshooting options, programming considerations, and possible causes. Next steps for consideration included defibrillation threshold (DFT) testing, measuring the noise to adjust sensing accordingly, or reviewing x-ray/fluoroscopic imaging to confirm lead location. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748341 ↗
• MalfunctionSep 10, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722578 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) and right ventricular (RV) lead was notified by their clinic of an alert associated with the implanted system. Technical Services (TS) was consulted; however, it could not be determined whether the alert was related to impedance measurements or signal amplitude measurements. The patient was subsequently evaluated in clinic, where noise was observed on the left ventricular (LV) channel. The local company representative performed troubleshooting to further assess the condition. Additionally, the patient reported that following the initial implant procedure, there had been fluid accumulation around the device and that the leads had perforated; however, no additional details regarding these reported events were available. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Cardiac Perforation

  MAUDE report 50708698 ↗
• MalfunctionSep 4, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50622120 ↗
• InjurySep 4, 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 50612594 ↗
• InjurySep 4, 2026Insufficient Device Problem Information; High Capture Threshold

  It was reported that, during a replacement procedure for normal battery depletion for the cardiac resynchronization therapy defibrillator (CRT-D), this right ventricular (RV) lead was surgically abandoned due to unknown circumstances. The replacement was successfully performed and a new lead was implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned to the laboratory for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602065 ↗
• InjurySep 4, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was surgically abandoned due to product performance issue. The replacement procedure was successfully performed and a new lead was implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned to the laboratory for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602061 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600877 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600876 ↗
• InjuryAug 22, 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 50387739 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378992 ↗
• InjuryAug 19, 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 50322240 ↗
• MalfunctionAug 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290585 ↗

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-2326-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
• 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,
• 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