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AquaShield 00711540Recalls & reported problems

US Endoscopy · The AquaShield system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. · 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 00724995183813), received between Aug 25, 2022 and Aug 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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

  • Improper Flow or Infusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 25, 2022Improper Flow or Infusion; Improper Flow or Infusion

    THE USER FACILITY REPORTED THAT THEIR AQUASHIELD WATER BOTTLE SYSTEM DID NOT PERFORM PROPERLY RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15293504 ↗

Other PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices

All PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE devices →

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