RELIANCE 4-FRONT™ 0650Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00802526592843), received between Oct 12, 2021 and Aug 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO LEAD WAS FRACTURED. A NEW LEAD WITH WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THE RV LEAD FRACTURE WAS CONFIRMED BY LEAD MEASUREMENTS AND AN X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920756 ↗
• MalfunctionOct 12, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS PATIENT'S REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. SUBSEQUENTLY, TROUBLESHOOTING WAS PERFORMED, AND THE COMMUNICATOR WAS POWER CYCLED, AND A SUCCESSFUL PATIENT-INITIATED INTERROGATION WAS SENT. THE PATIENT WAS REFERRED TO CONTACT THEIR CLINIC REGARDING THE RED CALL DOCTOR ICON. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT, MEASURING GREATER THAN 2000 OHMS. SUBSEQUENTLY, THIS PATIENT WAS BROUGHT INTO CLINIC FOR FURTHER TROUBLESHOOTING. THE PHYSICIAN OPTED TO TURN TACHY THERAPIES OFF FOR THIS PATIENT AT THAT TIME. AT THIS TIME, EVIDENCE SUGGESTS THE DEVICE SYSTEM REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620379 ↗

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