B/IS-15 SS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672102722), received between Jul 30, 2018 and Jul 30, 2018 — 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. 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.

• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT DEVELOPED AN INFECTION AND THERE WERE NO ALLEGATIONS AGAINST THE PRODUCTS. MOREOVER, THE FIELD REPRESENTATIVE VERIFIED THAT THE PREVIOUSLY ABANDONED LEADS WERE EXPLANTED. THE PATCHES AND EPICARDIAL LEADS WERE THEN CUT NEAR WHERE THEY ENTER THE CHEST, CAPPED WITH ALL THE EXCESS LEAD, CONNECTIONS AND ADAPTERS WERE EXPLANTED. FURTHERMORE, THE EXPLANTED PRODUCTS WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732558 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE DEVICE AND ADAPTOR WERE EXPLANTED, AND THE LEADS WERE ABANDONED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732502 ↗