OasisRecalls & reported problems across all models
Cook Ireland Ltd · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 15 models of Oasis by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2018 and Oct 29, 2025 — classified as 4 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Oasis problems
Device problems
- Difficult to Advance8
- Improper or Incorrect Procedure or Method6
- Activation, Positioning or Separation Problem5
- Material Deformation3
- Physical Resistance/Sticking2
- Break1
- Device Operational Issue1
- Failure to Advance1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient5
- Failure of Implant1
- Foreign Body In Patient1
- No Code Available1
Oasis models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Oasis G21739CATHETER, BILIARY, DIAGNOSTIC4 reports
- Oasis G25380CATHETER, BILIARY, DIAGNOSTIC4 reports
- Oasis G22150CATHETER, BILIARY, DIAGNOSTIC3 reports
- Oasis G25376CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25377CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25379CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25381CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25383CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25387CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25657CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25658CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G25659CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G26838CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G26849CATHETER, BILIARY, DIAGNOSTIC1 report
- Oasis G26853CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Oasis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
DESCRIPTION OF EVENT IMPOSSIBLE TO JETTISON THE PROSTHESIS AS PER CC FORM". UNABLE TO REMOVE THE STENT FROM THE ENDOSCOPE , THEY REMOVED THE PATIENT'S ENDOSCOPE AND REMOVED THE STENT STUCK AND THEN PUT ANOTHER BOSTON SCIENTIFIC BRAND STENT. PATIENT/EVENT INFO - NOTES 1. WHAT WAS THE TARGET LOCATION FOR THE STENT? BILE DUCT 3. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. NORMAL 4. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?* BRAND PIOLAX DIAMETER 0,35¿¿ 5. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES 6. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES 7. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES 8. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? SPHINCTEROTOMY 9. IF YES, PLEASE INDICATE THE TYPE OF PROCEDURE PERFORMED. SPHINCTEROTOMY. 10. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED?* ANOTHER STENT ( BOSTON SCIENTIFIC BRAND) 1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413814 ↗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 ↗MalfunctionOct 22, 2025Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance
A COMBINED CORRECTION AND COMPLETE SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 27-NOV-2025. (UPDATE TO IMDRF CODES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357894 ↗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 ↗MalfunctionAug 18, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 21-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836191 ↗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 ↗MalfunctionFeb 10, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance
FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9685903 ↗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 ↗MalfunctionDec 3, 2019Difficult to Advance; Difficult to Advance
USER OPENED THE PACKAGE AND FLUSH THE PORT WHILE FOUND OUT THE LUMEN BLOCK. USER TRIED TO ADVANCE A WIRE GUIDE THROUGH DEVICE AND FAILED. NO USE ON PATIENT. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9402218 ↗InjuryNov 21, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 05NOV2019--DID 05NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "I RECEIVED A PRODUCT COMPLAINT ON 10/25 REGARDING OUR STENT INTRODUCER IN RELATION TO A BILIARY PROCEDURE. CUSTOMER: THE (B)(6) HOSPITAL, (B)(6). CONTACT: (B)(6), LPN (LEAD ENDOSCOPY TECHNICIAN). GPN: G25380, LOT C1629388. DESCRIPTION: DURING AN ERCP, THE ENDOSCOPIST AND TECHNICIAN USED A STENT INTRODUCER TO ADVANCE A PLASTIC BILIARY STENT INTO THE WORKING CHANNEL OF A DUODENOSCOPE. UNKNOWINGLY, THE STENT INTRODUCER WAS ADVANCED BEYOND THE BIOPSY PORT AND INTO THE SCOPE. BECAUSE THE TEAM WERE UNAWARE OF THIS, NO ATTEMPT TO RETRIEVE THE INTRODUCER WAS MADE. WHEN THE SAME SCOPE WAS USED FOR ANOTHER PROCEDURE, IT WAS DISCOVERED THAT THE STENT INTRODUCER WAS STILL INSIDE THE SCOPE, AND WAS ADVANCED DOWN AND OUT OF THE SCOPE BY A NEW STENT. THE CUSTOMER RECOMMENDS THAT COOK CHANGE THE COLOR OF THE STENT INTRODUCER (IT IS CURRENTLY BLACK) OR NOT INCLUDE IT AT ALL IN THE STENT SET, AS THE CUSTOMER STATES THEY TYPICALLY DO NOT USE IT. AS FAR AS I KNOW, THE PATIENT HAS NOT BEEN AFFECTED BY THIS EVENT." ADDITIONAL INFORMATION PROVIDED ON 05NOV2019. "WHAT ENDOSCOPE WAS INVOLVED? A DUODENOSCO
Patient problems: Foreign Body In Patient
MAUDE report 9358164 ↗MalfunctionNov 20, 2019Material Deformation; Material Deformation
DURING ERCP, THE PLASTIC BILIARY PROSTHESIS WAS OPENED AND PASSED THROUGH THE ENDOSCOPE WORKING CHANNEL (DUODENOSCOPE), BUT IT DID NOT FIRE. IT WAS IMPACTED ON THE GUIDE WIRE. IT WAS BENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9350955 ↗InjuryNov 13, 2019Unintended Movement; Unintended Movement
AS REPORTED BY THE INITIAL REPORTER: "I RECEIVED A PRODUCT COMPLAINT ON (B)(6) REGARDING OUR STENT INTRODUCER IN RELATION TO A BILIARY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, "DURING AN ERCP, THE ENDOSCOPIST AND TECHNICIAN USED A STENT INTRODUCER TO ADVANCE A PLASTIC BILIARY STENT INTO THE WORKING CHANNEL OF A DUODENOSCOPE. UNKNOWINGLY, THE STENT INTRODUCER WAS ADVANCED BEYOND THE BIOPSY PORT AND INTO THE SCOPE. BECAUSE THE TEAM WERE UNAWARE OF THIS, NO ATTEMPT TO RETRIEVE THE INTRODUCER WAS MADE. WHEN THE SAME SCOPE WAS USED FOR ANOTHER PROCEDURE, IT WAS DISCOVERED THAT THE STENT INTRODUCER WAS STILL INSIDE THE SCOPE, AND WAS ADVANCED DOWN AND OUT OF THE SCOPE BY A NEW STENT." IT WAS FURTHER REPORTER THAT "THE PATIENT HAS NOT BEEN AFFECTED BY THIS EVENT." ADDITIONAL INFORMATION PROVIDED ON 05NOV2019, A DUODENOSCOPE WAS USED DURING THE PROCEDURE.
Patient problems: No Code Available
MAUDE report 9317284 ↗MalfunctionOct 21, 2019Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance
EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. AFTER THE DOCTOR PLACE THE WHOLE DEVICE INTO THE BILE DUCT, THEY UNLOCK THE PUSHER, TRY TO PUSH THE PUSHER IN, BUT IT STUCK, THEY CANNOT PUSH THE PUSHER IN. SO THEY USE ANOTHER NEW DEVICE
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9213179 ↗MalfunctionAug 26, 2019Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance
A MALE PATIENT UNDERWENT A PROCEDURE TO PLACE 1 OASIS ONE ACTION STENT, G25383, TO DRAIN AN ABSCESS IN THE UPPER HEPATIC DUCT. THE PRE-LOADED PLASTIC STENT WAS PLACED INTO THE ABSCESS AT WHICH POINT THE DR. ASKED MYSELF AND MY REGIONAL MANGER MATTHEW HENDERSON IF WE CHANGED HOW WE MADE OUR STENTS? ONCE WE LOOKED CLOSER AT THE PLACED STENT IT WAS CLEAR THAT IT WAS IN BACKWARDS AND THAT IT WAS PACKAGED PRELOADED ONTO THE INTRODUCER BACKWARDS (PR272880). THE STENT, ALTHOUGH BACKWARDS, WAS COMPLETING DRAINAGE AS NEEDED AND NO FURTHER ACTION WAS TAKEN. THE STENT WAS LEFT IN THE PATIENT AND COMPLICATIONS WERE NOT EXPECTED, WE SIMPLY NEED TO POINT OUT THE ASSEMBLY ERROR TO FURTHER MAKE SURE THIS ISN'T HAPPENING MORE OFTEN THAN NOT. THE DOCTOR DID STATE THAT HE HAS SEEN THIS BEFORE (PR273723), HOWEVER HE HAD BLAMED THE FELLOW PLACING THE STENT NOT REALIZING IT WAS PRELOADED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8930759 ↗MalfunctionJul 23, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
INTRODUCER HUB OF OATS-8.5-12/ LOT C1563536 CAME OFF. [UPDATED ON 27/JUNE/2019 (B)(4)] ERCP & STENT EXCHANGE WERE PERFORMED. PRE-EXISTING OATS-8.5-12 WAS REMOVED WITH A FORCEPS. THEN, CANNULATION WAS PERFORMED AND BOSTON SCIENTIFIC'S JAGWIRE 0.035" WAS ADVANCED TO THE BILE DUCT. AFTER THAT, OATS-8.5-12/ LOT C1563536 WAS ADVANCED OVER THE WIRE GUIDE. THE STENT REACHED PROPER POSITION TO PLACE AND THEN THE USER DISCONNECTED LUER LOCK FITTING ON THE INTRODUCER AND ADVANCED THE POSITIONING SLEEVE BUT THE USER FELT SOME RESISTANCE. HE CHECKED THE ELEVATOR OF THE ENDOSCOPE AND CONFIRMED IT IN THE DOWN POSITION. THEREFORE HE CONTINUED ADVANCING THE POSITIONING SLEEVE WITH HOLDING THE INTRODUCER FITTING BUT THE FITTING CAME OFF DURING THE ADVANCEMENT. HE HOLDED THE INTRODUCER SHAFT WITH HIS HAND AND PLACED THE STENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8815957 ↗
Other Cook Ireland Ltd products
All Cook Ireland Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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