ENDOTAK RELIANCE® G 0176Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00802526376726), received between Jul 3, 2020 and Oct 1, 2020 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Jul 24, 2025Class IOpen, Classified

   Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

   Z-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionOct 1, 2020High impedance; High impedance

  IT WAS REPORTED THAT PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL WERE 2300-3000 OHMS DURING IMPLANT TESTING. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER THE LEAD WAS REPOSITIONED WHICH PRODUCED STABLE IMPEDANCE MEASUREMENTS. THE SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10616651 ↗
• MalfunctionJul 3, 2020Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM, AS THE PATIENT RECEIVED EIGHT INAPPROPRIATE SHOCKS. THIS WAS A RESULT OF RIGHT VENTRICULAR (RV) LEAD OVERSENSING. NO FURTHER INFORMATION WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. EVIDENCE SUGGESTS THAT THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED.

  Patient problems: Electric Shock

  MAUDE report 10227879 ↗

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,