BIOSURE 72203253Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554027198), received between Jun 17, 2020 and Jun 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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.

• MalfunctionJun 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE FLEXIBLE TAP WAS FOUND BROKEN BEFORE THE CASE. THERE WAS A BACK-UP DEVICE AVAILABLE. NO DELAY OCCURRED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10212723 ↗
• MalfunctionJun 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE BIOSURE 7MM WAS FOUND TO BE BROKEN BEFORE THE CASE. UNKNOWN IF THERE WAS BACKUP AVAILABLE OR IF THE PROCEDURE WAS DELAYED. NO OTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10165659 ↗