Oasis G22150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002221505), received between Apr 19, 2018 and Jul 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE DOCTOR INTENDED TO USE TTSO-8.5-13 ALONG WITH OA-8.5 FOR DRAINAGE IN THE CBD STRICTURE AREA. AS USUAL, TTSO-8.5-13 WAS PRELOADED INTO OA-8.5 AND APPROACHED INTO THE CBD. THE INNER GUIDING CATHETER WAS POSITIONED ALONG THE WIRE, BUT DURING THE PROCESS OF INSERTING THE STENT, THE INNER GUIDING CATHETER DID NOT SEPARATE WELL AND THE SHEATH STRETCHED. THERE WAS SIGNIFICANT RESISTANCE, AND AFTER MUCH DIFFICULTY, TTSO-8.5-13 WAS POSITIONED, AND THE INNER GUIDING CATHETER WAS SEPARATED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561895 ↗
• MalfunctionDec 12, 2019Use of Device Problem; Use of Device Problem

  THE DEVICE WAS USED FOR BILIARY STENT PLACEMENT. THE TARGET SITE WAS THE LOWER BILE DUCT, AND THE STENT COULD REACH THERE WITH A PUSHER. HOWEVER, IT COULD NOT BE RELEASED. THEREFORE, ANOTHER MANUFACTURE¿S DEVICE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9456767 ↗
• MalfunctionApr 19, 2018Device Operational Issue; Device Operational Issue

  LEFT HEPATICUS WAS REACHED BY WIRE GUIDE, THAN USED DILATOR 8,5 FR AFTER DILATATION WAS USED OA-8.5 WITH PLASTIC STENT PBS. IT WASN'T POSSIBLE TO GO THROUGH AND THERE WAS BROKEN GUIDING AND ALSO PUSHING CATHETER. WIRE GUIDE WAS STUCK INSIDE THE GUIDING CATHETER. ALL DEVICES WERE REMOVED FROM THE PATIENT. SECOND ATTEMPT TO DRAIN THE LEFT HEPATICUS WASN'T PERFORMED. PATIENT HAS DRAINED RIGHT HEPATICUS ONLY. REPORTING DUE TO THE PRECEDENCE OF "DIFFICULT ADVANCEMENT" FOR THIS PRODUCT FAMILY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442749 ↗