Fusion Oasis G31526Recalls & reported problems
Cook Ireland Ltd · Fusion Oasis, One Action Stent Introduction System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002315266), received between Mar 7, 2018 and Nov 18, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Difficult to Advance1
Patient problems
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2019Break; Break
THE CATHETER BROKE OFF AT THE DISTAL END DURING THE PROCEDURE. CUST. WANTS CREDIT NOTE AND REPORT. "AS PER COMPLAINT FORM": WHILE TRYING TO PUSH THE STENT INTO THE CBD THE PUSHER SEEMED KINKED FROM THE BEGINNING, IMPOSSIBLE TO PUSH STENT IN.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 9334480 ↗MalfunctionMar 7, 2018Difficult to Advance; Difficult to Advance
THE GUIDING CATHETER WAS EASILY WITHDRAWN UNTIL THEY COULDN¿T PULL ANYMORE; DR SAID IT WAS A REAL DIFFICULT CASE (DUODENOSCOPE VERY TWISTED AND IN LONG SCOPE POSITION) BUT THE NURSE SAID THAT IT WAS CAUSE BECAUSE THE WIRE GUIDE WAS LEFT IN IDE PORT. PATIENT NOT INJURED. "AS PER COMPLAINT FORM": STENT COULDN'T BE DEPLOYED, GUIDING CATHETER NOT MOVING. WORKING IN A DIFFICULT POSITION (DUODENUM) AND IN LONG SCOPE POSITION; DIFFICULTIES TO PUSH THE STENT INTO PAPILLAE AND TUMOUR. DR ASKED TO PULL "GUIDING CATHETER" BUT IT WAS VERY DIFFICULT SO DR. GOT NERVOUS AND ASKED TO PULL AS HARD AS POSSIBLE; NEVERTHELESS NURSE GUESSED THE WIRE GUIDE WAS STILL IN IDE PORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7319705 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page