BioShield 00711133 (UDI 00816765011102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816765011102), received between Aug 22, 2018 and Sep 11, 2020 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED TWO INSTANCES OF PATIENT MATERIAL IN THE TUBING CONNECTED TO THE ONE-WAY VALVE OF THE BIOSHIELD IRRIGATOR FOLLOWING A PATIENT PROCEDURE. THE TUBING AND WATER BOTTLE WERE REPLACED PRIOR TO THE NEXT PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM NOR OF PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10521139 ↗
• MalfunctionJan 17, 2020Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT FLUID SPRAYED FROM THE CAP OF THE BIOSHIELD IRRIGATOR. NO HARM TO PATIENT OR USERS WAS REPORTED. THE TECHNICIAN WAS WEARING PPE AND THERE WAS NO REPORT OF DIRECT CONTACT WITH THE FLUIDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9601123 ↗
• MalfunctionMay 24, 2019Fluid/Blood Leak; Loose or Intermittent Connection

  THE DISTRIBUTOR REPORTED MULTIPLE INSTANCES OF THE CAP OF THE BIOSHIELD IRRIGATOR OPENING DURING PROCEDURES, RESULTING IN LIQUID BEING PROJECTED FROM THE BIOPSY PORT. NO HARM TO PATIENTS OR USERS WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8641706 ↗
• MalfunctionAug 22, 2018Material Disintegration

  THE USER FACILITY REPORTED DEBRIS IN THE TUBING CONNECTED TO THE BIOSHIELD IRRIGATOR DEVICE FOLLOWING A PROCEDURE. NO PATIENT OR USER HARM WAS REPORTED.

  MAUDE report 7806919 ↗