BioShield 00711125 (UDI 10816765013394)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10816765013394), received between Aug 15, 2018 and Jun 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 20, 2019Fluid/Blood Leak; Unintended Movement

  THE USER FACILITY REPORTED THE CAP OF THE BIOSHIELD BIOPSY VALVE OPENED DURING A PROCEDURE, RESULTING IN A SPRAY OF BODILY FLUID WHICH CONTACTED A TECHNICIAN'S PPE. NO HARM TO PATIENT OR USERS WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 8718504 ↗
• MalfunctionAug 15, 2018Fluid/Blood Leak

  THE DISTRIBUTOR IN THE (B)(4) RECEIVED REPORT OF BODILY FLUID SPRAY WITH RESULTANT PATIENT AND USER CONTACT DURING PASSAGE OF DEVICES THROUGH BIOSHIELD BIOPSY VALVES.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7786146 ↗