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AquaShield
US Endoscopy · Model 00711549 · UDI-DI 00816765012222
FEQ
Prescription
10
510(k) clearances
1,316
Adverse events (2 deaths)
5
Recalls
46
Facilities
Description
The AquaShield CO2 system is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-31 | Erbe Medical, LLC | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl |
| 2024-08-23 | Olympus Corporation of the Americas | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. |
| 2015-09-11 | Olympus Corporation of the Americas | small puncture marks in a sterile package for an accessory to an Olympus device |
| 2013-05-20 | Olympus America Inc. | There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump |
| 2011-12-12 | Olympus America Inc. | Water may leak from the irrigation tubing used on the Olympus Flushing Pump |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.