RELIANCE 4-FRONT™ 0672Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,895 adverse event reports that list this exact device (DI 00802526592829), received between Jan 28, 2019 and Sep 30, 2026 — classified as 13 deaths, 2,198 injuries, 684 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (471 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,895 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50953420 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941342 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50940072 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938703 ↗
• MalfunctionSep 29, 2026High impedance; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934815 ↗
• MalfunctionSep 29, 2026High impedance

  It was reported that the implantable cardioverter defibrillator (ICD) and this right ventricular (RV) lead exhibited a high out of range shock impedance measurement at 129 Ohms. The shock impedance was back to baseline and was in normal limits. No other lead measurements were out of range. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933348 ↗
• MalfunctionSep 29, 2026High impedance

  It was reported that this single coil right ventricular (RV) defibrillation lead exhibited a gradual rise in shock impedances that appeared to plateau off to high out-of-range measurements greater than 125 Ohms. Technical Services (TS) discussed troubleshooting options and programming considerations for continued monitoring. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927559 ↗
• MalfunctionSep 28, 2026Failure to Read Input Signal; Under-Sensing; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918058 ↗
• InjurySep 28, 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 50917575 ↗
• InjurySep 28, 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 50910882 ↗
• InjurySep 28, 2026Device Sensing Problem; Impedance Problem; Positioning Problem

  It was reported that this right ventricular (RV) lead exhibited sensing and impedance anomalies during testing performed after implantation. Subsequently, multiple attempts were made by the physician to reposition the lead; however, acceptable electrical measurements could not be obtained. The procedure was ultimately completed using a different lead, after which stable sensing and impedance measurements were achieved. 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 50910872 ↗
• InjurySep 25, 2026Failure to Convert Rhythm

  It was reported that this implantable cardioverter defibrillator (ICD) did not convert the patient ventricular tachycardia (VT) events with the right ventricular (RV) lead. The physician and Technical Services (TS) discussed potential lead changeout and repositioning. The patient has a history of failed defibrillation threshold (DFT) tests. Subsequently this RV lead was explanted and replaced. A new lead was successfully implanted as a replacement. This lead has not been received for investigation. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898850 ↗
• InjurySep 25, 2026Device Dislodged or Dislocated

  It was reported that this right atrial (RA) lead was explanted due to dislodgement. This RV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897595 ↗
• InjurySep 24, 2026Device Dislodged or Dislocated

  It was reported that the patient with this right ventricular (RV) lead was seen in the emergency room and admitted due to sharp pain with cough on the left side and chest pain. Laboratory tests, imaging device and electrocardiogram were taken. Scheduled lead revision was to be determined. At this time, this RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Chest Pain; Cough

  MAUDE report 50884378 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient with this right ventricular (RV) lead was checked due to chest pain. During the evaluation, patient jolted in pain every time the RV lead did any pacing. An ultrasound and computed tomography (CT) scan were performed and confirmed RV lead have perforated through the myocardium. There was no tamponade and pericardial effusion was noted. Also, the lead exhibited high threshold. Subsequently, the RV lead was surgically repositioned and to date, the lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Chest Pain; Perforation

  MAUDE report 50879337 ↗
• InjurySep 23, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; High Capture Threshold

  Patient problems: Bradycardia; Malaise

  MAUDE report 50876216 ↗
• MalfunctionSep 23, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876196 ↗
• MalfunctionSep 23, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874353 ↗
• 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 and received for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873534 ↗
• InjurySep 23, 2026Failure to Capture; Low impedance

  It was reported that this right ventricular (RV) lead exhibited a drop in pace impedance measurements from 402 to 296 Ohms and no capture at maximum output. This lead was subsequently explanted and replaced. This lead has not been returned for analysis. Other than the surgical procedure, no additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873326 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead was explanted due to the patient suffering an infection. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50818013 ↗
• MalfunctionSep 17, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811600 ↗
• 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 50809504 ↗
• InjurySep 17, 2026Failure to Capture; Low impedance; High Capture Threshold

  It was reported that the patient experienced sternal stimulation with this right ventricular (RV) lead which exhibited loss of capture, high threshold, pacing impedance drop. Fluoroscopy was suggestive of perforation. This RV lead was surgically repositioned and remains in service. No additional adverse patient effects were reported.

  Patient problems: Device Overstimulation of Tissue; Perforation

  MAUDE report 50805505 ↗
• 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 50797986 ↗

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