ENDOTAK RELIANCE® SG 0292Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,197 adverse event reports that list this exact device (DI 00802526531248), received between Jul 1, 2014 and Sep 30, 2026 — classified as 16 deaths, 1,942 injuries, 1,239 malfunctions.

The most frequently reported specific device problem is “High impedance” (1,487 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 3,197 reports, 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 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 11, 2026High impedance

  It was reported that this right ventricular (RV) lead recorded high out of range shock impedance measurements. Current shock impedance measurements were reported in the 130-ohm range, while the alert threshold was programmed at 150 ohms. Technical Services (TS) reviewed the data and historical device data review indicated that shock impedance measurements from approximately two years prior were between 85 and 90 ohms. Continued monitoring was recommended. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725375 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this previously capped right ventricular (RV) lead was part of a system revision due to infection. There were no additional adverse patient effects reported. The previously capped RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50713630 ↗
• MalfunctionSep 4, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock lead impedances. The rise in measurements was noted to be gradual. Technical Services (TS) recommended potential programming changes for the device. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612126 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611795 ↗
• InjurySep 4, 2026Signal Artifact/Noise; Fracture; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) system presented to the emergency room (ER) and claimed they received shocks. It was noted the patient had been non-compliant, and data showed the device reached Elective Replacement Indicator (ERI) approximately eight months ago. It was also noted remote monitoring was disabled approximately three months ago. Technical Services (TS) reviewed the data and confirmed the device was at End of Life (EOL) and there would be no way to see whether the patient received therapy. It was not determined whether the patient was shocked, and whether therapy was appropriate or not. Information from the field was received and noted there was a fracture in the right ventricular (RV) lead and that the patient may have received inappropriate shocks due to the noise on the lead from the fracture. It was also noted both brady and tachy therapy was turned off. The patient was scheduled to follow up with the physician. No additional adverse patient effects were reported. This RV lead remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50610052 ↗
• InjurySep 4, 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 50606765 ↗
• InjurySep 4, 2026High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602918 ↗
• MalfunctionSep 4, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited an increase in shocking impedances measurements. Technical Services (TS) recommended to keep monitoring. The measurements are still within normal limits, and the RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602917 ↗
• InjurySep 4, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) visited the emergency room (ER) for evaluation after receiving shocks. Technical Services (TS) was called for consult review of device data. The device was interrogated however, due to device being in End of Life (EOL) battery status, the episodes were unable to be reviewed to determine shocks were appropriate or not because device does not store episodes when in EOL status. TS reviewed the stored daily threshold and impedance measurements trend reports which showed high out of range shock impedances measurements on the right ventricular (RV) lead that appeared to have been gradually increasing since 2018. The clinician opted to continue with monitoring. The RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50601343 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this right ventricular (RV) lead had an infection. A revision was performed and the cardiac resynchronization therapy defibrillator (CRT-D) with the right ventricular (RV) lead, right atrial (RA) lead and left ventricular (LV) lead were explanted. No additional adverse patient effects were reported. The RV lead was not returned for analysis.Additional information from the field indicates that the patient was prescribed antibiotics. Additionally, the patient aspirated after the procedure and subsequently passed away as a result. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50570035 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead had exhibited infection due to infected breast implant. As of this time, this RV lead remains in service. There was no additional adverse patient effects reported.

  Patient problems: Unspecified Infection

  MAUDE report 50566535 ↗
• MalfunctionAug 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509694 ↗
• InjuryAug 24, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedance measurements of 137 ohms. The impedance trend demonstrated a gradual increase over time. The physician opted to surgically abandon and replace this lead. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416028 ↗
• InjuryAug 22, 2026Fracture; High impedance; Material Integrity Problem

  It was reported that this right ventricular (RV) defibrillation lead fracture was suspected due to a sudden spike in shock impedances to greater than 200 Ohms. Subsequently, this RV lead was explanted and replaced. During extraction, it was noted that it was not possible to cannulate the lead past the shocking coil to the tip. No additional adverse patient effects were reported. Product return was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50384384 ↗
• MalfunctionAug 21, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374605 ↗
• MalfunctionAug 19, 2026Pacing Problem

  Patient problems: Asystole; Bradycardia

  MAUDE report 50329750 ↗
• MalfunctionAug 19, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50315439 ↗
• InjuryAug 18, 2026High impedance; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted due to an product performance issue. This RV lead was successfully explanted and replaced with another lead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311708 ↗
• MalfunctionAug 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50310115 ↗
• MalfunctionAug 14, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263455 ↗
• 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. This RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50255876 ↗
• InjuryAug 12, 2026Impedance Problem

  It was reported that this right ventricular (RV) exhibited an out of range impedance measurement. The patient underwent a medical intervention to surgically abandon the lead and implant a new RV lead. It was reported that the patient was stable and no additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228396 ↗

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