Dissector MID1 (REF A000195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818354010367), received between Jun 30, 2024 and Jun 30, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT BILATERAL TT MAZE PROCEDURE USING A MID1 DISSECTOR. NEAR THE COMPLETION OF PROCEDURE, AN INJURY TO THE DOME OF THE LEFT ATRIUM OCCURRED. THE SURGEON DECIDED TO CONVERT ACCESS TO A STERNOTOMY TO REPAIR THE INJURY. THE INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. THIS WAS A PROCEDURAL COMPLICATION, AND THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19641005 ↗