BIS/BLV-4402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672003692), received between Aug 2, 2017 and Feb 22, 2022 — classified as 2 injuries.

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

• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE UNDERWENT A PROCEDURE FOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). EXTRACTION WAS PERFORMED DUE TO INFECTION, HOWEVER, IT WAS REPORTED THAT AN EPICARDIAL LEAD APPEARS TO BE ABANDONED. THERE WAS NO KNOWN DEVICE ISSUE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13579782 ↗
• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE WAS EXPLANTED ON (B)(6) 2017 DUE TO INFECTION, HOWEVER, IT WAS REPORTED AN EPICARDIAL LEAD WAS ABANDONED SURGICALLY. THIS DEVICE WILL NOT BE RETURNED AS THE DEVICES WERE DISPOSED OF.

  Patient problems: Unspecified Infection

  MAUDE report 6761886 ↗