NA 6931Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526067884), received between Jul 2, 2018 and Sep 14, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE LEAD ADAPTOR WAS SURGICALLY ABANDONED DUE TO UNSPECIFIED PRODUCT PERFORMANCE ISSUES. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417621 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ADAPTER LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER LEAD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11788348 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS ADAPTER LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER LEAD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11788343 ↗
• InjuryJan 31, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS ADAPTER WAS ABANDONED, AS LEAD WHERE IT WAS CONNECTED EXHIBITED HIGH PACING THRESHOLDS AND NOISE, ROOT CAUSE WAS NOT DETERMINED. LATER ON THE ADAPTER WAS EXPLANTED AN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Code Available

  MAUDE report 9654367 ↗
• InjuryJan 31, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS ADAPTER WAS ABANDONED, AS LEAD WHERE IT WAS CONNECTED EXHIBITED HIGH PACING THRESHOLDS AND NOISE, ROOT CAUSE WAS NOT DETERMINED. LATER ON THE ADAPTER WAS EXPLANTED AN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Code Available

  MAUDE report 9653916 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ACCESSORY ADAPTER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7663036 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ACCESSORY ADAPTER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7663035 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ACCESSORY ADAPTER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7654469 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ACCESSORY ADAPTER WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ADAPTER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7654458 ↗

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-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,