Oasis G21739Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002217393), received between Jun 27, 2018 and Oct 29, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED VIA EMAIL: "PLASTIC LUER LOCK FITTING DISCONNECTED FROM GUIDING CATHETER DURING STENT DEPLOYMENT." 1. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO 2. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? ERCP 3. WHAT WAS THE TARGET LOCATION FOR THE STENT? CBD 4. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED IN CLIMATE CONTROLLED ROOM, IN A CABINET. 5. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?* .025 OLYMPUS VISIGLIDE 6. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES 7. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES 8. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES 9. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? 1. (IF YES, PLEASE INDICATE THE PROCEDURE PERFORMED.) YES 10. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO 11. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO 1. (IF YES, P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413092 ↗
• MalfunctionAug 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE STENT COULD NOT BE DEPLOYED USING THE OA-10, THE PHYSICIAN ASSISTANT FELT IT COULD NOT BE PULLED BACK. ADDITIONAL INFORMATION RECEIVED ON 31-JULY-2025 1. WHAT WAS THE TARGET LOCATION FOR THE STENT? BILIARY DUCT, 2. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. AS PER STANDARD PROTOCOL OF AN ISO CERTIFIED HOSPITAL. 3. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? VIZIGLIDE ¿ 0.025 INCH X 450 CM 4. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? N/A, YES, 5. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE?* YES 6. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? N/A, 7. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? NO 8. IF YES PLEASE INDICATE THE TYPE OF PROCEDURE PERFORMED. 9. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO 10. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED?* WITH ANOTHER OA-10 11. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860046 ↗
• InjuryNov 30, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS FILE IS DEALING WITH THE OA-10 MALFUNCTIONING, AN ADDITIONAL FILE HAS BEEN OPENED TO CAPTURE CLSO-10-7. HALF WAY DEPLOYING THE CLSO-10-7, THE OA-10 GOT STUCK, CANNOT PUSH FURTHER, SO WE HAD TO REMOVE THE OA-10 & GUIDEWIRE. BECAUSE HALF OF THE STENT IS IN THE COMMON BILE DUCT, THE OTHER HALF OUTSIDE PAPILA, WE HAD TO USE A BIOPSY FORCEP TO PUSH IT INTO THE DUCT. FEW HOURS LATER, DOCTOR HAD TO REMOVE THE STENT BECAUSE XRAY SHOWS THAT IT WAS IN THE WRONG TRACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8118905 ↗
• MalfunctionJun 27, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REPORTING DUE TO MODERATE RISK. WHEN PLACING A 10 CM PLASTIC STENT (TTSO-10-10), THE PUSHER KINKED IN THE DUODENUM SO THEY HAD TO REPLACE IT IN ORDER TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641668 ↗