RELIANCE 4-FRONT™ 0652Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00802526592812), received between Jul 23, 2020 and Sep 28, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “High impedance” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50917392 ↗
• MalfunctionNov 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IT WAS OBSERVED THAT THE PATIENT HAD BEEN IN AN INTRINSIC ATRIAL FIBRILLATION EPISODE, MEDICATION WAS ADMINISTERED IN ORDER TO TAKE THE PATIENT OUT OF THIS EPISODE. AFTER THIS, THE IMPEDANCE MEASUREMENTS LOWERED. MONITORING OF THE PATIENT WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794014 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD AND ALL OF THE SYSTEM WERE SURGICALLY EXPLANTED AND REPLACED WITH A NEW SYSTEM THE SAME DAY DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11211981 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10318263 ↗

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,
• 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