RELIANCE 4-FRONT™ 0673Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,173 adverse event reports that list this exact device (DI 00802526592867), received between Nov 7, 2018 and Sep 30, 2026 — classified as 10 deaths, 1,638 injuries, 525 malfunctions.

The most frequently reported specific device problem is “High impedance” (300 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,173 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the patient passed away on (B)(6) 2026. During a routine cardiac resynchronization therapy defibrillator (CRT-D) system implant, the patient experienced cardiac arrest. The cardiac arrest occurred while the left ventricular (LV) lead was being implanted and after this right ventricular (RV) lead was implanted. Backup pacing was provided on this RV lead. Cardiopulmonary resuscitation (CPR) was given to the patient, and the patient experienced ventricular tachycardia (VT) and ventricular fibrillation (VF) several times. The field representative noted the patient was stable after the procedure. It was later reported by the field representative that the patient passed away overnight. It was noted the CRT-D was never implanted in the patient. This RV lead was an attempted implant. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 50950618 ↗
• MalfunctionSep 30, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949563 ↗
• MalfunctionSep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947730 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936104 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923938 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50919971 ↗
• MalfunctionSep 28, 2026Over-Sensing

  Patient problems: Asystole

  MAUDE report 50915187 ↗
• MalfunctionSep 28, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914163 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead was explanted due to a product performance anomaly. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899775 ↗
• InjurySep 25, 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. The patient was treated with antibiotics. There were no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50895843 ↗
• MalfunctionSep 24, 2026Low impedance

  It was reported that this right ventricular (RV) lead exhibited low out of range shock impedance measurements. Technical Services (TS) was consulted and found the value to be 0 ohms. TS discussed with the local field representative that this is unlikely true and an external source caused the out of range value. If no external source is found to be the root cause, TS recommended in person evaluation of the lead. No adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882948 ↗
• MalfunctionSep 24, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited rising pace impedances since (b)(6) 2025. Pace impedance measurements had increased from 650 Ohms at implant to a high out-of-range pace impedance measurement of 2,010 Ohms. Shock impedances remained stable since implant, with measurements in the 80-100 Ohms range. Technical Services (TS) discussed troubleshooting options, programming considerations, and possible causes. This RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877123 ↗
• MalfunctionSep 23, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876107 ↗
• MalfunctionSep 23, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876057 ↗
• DeathSep 17, 2026Failure to Convert Rhythm; Failure to Read Input Signal; Under-Sensing

  It was reported that during a device upgrade procedure, defibrillation threshold (DFT) testing was performed but was unsuccessful as the right ventricular (RV) defibrillation lead could not detect and convert. The paced QRS was 2.5mV, the induced VF was not detected and an external shock was delivered to convert the arrhythmia. The RV lead was repositioned, sensitivity was adjusted and the paced QRS was now 4.2mV. DFTs failed at 21 Joules and 31 Joules in the initial polarity, then was successful at 31 Joules in reversed polarity. In total, 11 DFTs were performed. The patient passed away over the weekend; there were no allegations against the implanted device but the physician was looking to see if any episode EGMs were available. Technical services discussed there was no LATITUDE data and recommended interrogating the device post-mortem. It was noted that the patient had undergone a coronary artery bypass graft (CABG) one week before. Additional information was received confirming the device was not interrogated post-mortem and the device and lead were not explanted for return. The official cause of death was not provided to the local sales representative and the physician did not

  Patient problems: Insufficient Information

  MAUDE report 50809993 ↗
• 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. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50783384 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated; Insufficient Device Problem Information; High Capture Threshold

  It was reported that this right ventricular (RV) lead was explanted due to an unknown product anomaly. A new lead was implanted. No additional adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754169 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50739624 ↗
• InjurySep 9, 2026Signal Artifact/Noise; Fracture; High impedance; Mechanical Problem; Over-Sensing; Pacing Problem; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702989 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698553 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50678105 ↗
• InjurySep 8, 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. This RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50677337 ↗
• InjurySep 8, 2026High Capture Threshold

  It was reported that this right ventricular (RV) lead exhibited elevated threshold measurements and outputs were above 6. volts. The device had 1.5 years remaining at the elevated outputs. This RV lead was surgically revised and remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668687 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652982 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 50652278 ↗

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-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-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-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