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BioShield 00711136Recalls & reported problems

US Endoscopy · The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816765011133), received between Jun 5, 2020 and Jun 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 5, 2020Fluid/Blood Leak

    THE DISTRIBUTOR REPORTED THAT DURING USAGE OF THE BIOSHIELD BIOPSY VALVE ON A BRONCHOSCOPE, FLUID PROJECTED FROM THE CAP WHEN INJECTING SALINE. NO HARM TO PATIENT OR USERS WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10125314 ↗

Other Endoscopic retrograde cholangiopancreatography (ERCP) cannula devices

All Endoscopic retrograde cholangiopancreatography (ERCP) cannula devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.