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BioShield 00711124Recalls & reported problems

US Endoscopy · The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816765011034), received between Jul 20, 2018 and Aug 8, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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

  • Device Contamination with Body Fluid1
  • Fluid/Blood Leak1
  • Leak/Splash1

Patient problems

  • Chemical Exposure1
  • Conjunctivitis1
  • Exposure to Body Fluids1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 8, 2019Fluid/Blood Leak

    THE DISTRIBUTOR REPORTED USER CONTACT (FACIAL) WITH FLUID SPRAY FROM THE BIOSHIELD BIOPSY VALVE. THE USER IS REPORTED TO HAVE SUBSEQUENTLY DEVELOPED CONJUNCTIVITIS.

    Patient problems: Chemical Exposure; Conjunctivitis

    MAUDE report 8875113 ↗
  • MalfunctionAug 27, 2018Device Contamination with Body Fluid

    THE DISTRIBUTOR IN THE (B)(4) RECEIVED REPORT OF BODILY FLUID SPRAY DURING PASSAGE OF DEVICES THROUGH BIOSHIELD BIOPSY VALVES. THERE WAS NO REPORT OF PATIENT OR USER CONTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7820450 ↗
  • MalfunctionJul 20, 2018Leak/Splash

    THE DISTRIBUTOR IN THE (B)(6) RECEIVED REPORT OF BODILY FLUID SPRAY WITH RESULTANT PATIENT AND USER CONTACT DURING INSERTION AND WITHDRAWAL OF DEVICES THROUGH BIOSHIELD BIOPSY VALVES.

    Patient problems: Exposure to Body Fluids

    MAUDE report 7705878 ↗

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.