SolusRecalls & reported problems across all models
Cook Ireland Ltd · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 7 models of Solus by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 28, 2018 and Aug 17, 2026 — classified as 3 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (10 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 Solus problems
Device problems
- Difficult to Advance10
- Improper or Incorrect Procedure or Method6
- Physical Resistance/Sticking4
- Failure to Advance3
- Migration3
- Deformation Due to Compressive Stress1
- Dent in Material1
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient6
- Pain1
- Ulcer1
Solus models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Solus G25672CATHETER, BILIARY, DIAGNOSTIC5 reports
- Solus G25673CATHETER, BILIARY, DIAGNOSTIC5 reports
- Solus G25670CATHETER, BILIARY, DIAGNOSTIC4 reports
- Solus G25671CATHETER, BILIARY, DIAGNOSTIC3 reports
- Solus G25685CATHETER, BILIARY, DIAGNOSTIC3 reports
- Solus G25674CATHETER, BILIARY, DIAGNOSTIC1 report
- Solus G25675CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Solus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Migration
Description of EventThe physician reported a cumulative total of 3 cases where the distal pigtail repeatedly eroded against the duodenal wall, causing duodenal ulcers.Patients began experiencing pain approximately one month post-placement, forcing the physician to perform premature stent removal.Currently, this stent is only available in a single thickness of 10Fr, with no other size options provided.It is unclear whether this issue stems from the product design (e.g., pigtail configuration/size) or material hardness (e.g., high durometer causing tissue erosion).Therefore, the physician has submitted a formal product complaint requesting a full investigation by the manufacturer.Patient/Event Info - NotesTRIAGE REQUESTED - (b)(6)2026:1. Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Room temperature 25 °C, storage in closet.2. What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?This problem occurred during the period of stenting. There were no reorder stent.3. Was the wire guide lubricated prior to use? "[N/A, Yes, No]"Yes.4. Was the wire gu
Patient problems: Pain; Ulcer
MAUDE report 50272695 ↗MalfunctionAug 17, 2026Migration
Description of Event:The doctor is an experienced user of this product line, so user error has been completely ruled out.This doctor has encountered two cases where the stent spontaneously migrated and was expelled via the GI tract in less than one month post-placement.During placement, the stent was anchored deeply into the IHD.Although the product feature and indication specify a dwell time of up to 6 months, these stents migrated within just 1 month.The physician noted that migration never occurred with the previously used Zimmon stents.However, two of these double pigtail stents migrated within one month.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272680 ↗MalfunctionMar 24, 2026Improper or Incorrect Procedure or Method; Physical Resistance/Sticking
WHEN PHYSICIAN PUSH STENT OVER THE STENOSIS, HE WANTED TO PULL BACK THE INNER CATHETER. HE FOUND THAT HE COULDN'T PULL BACK HE INNER CATHETER, HE USED FORCE TO IT AND LED THE CATHETER BROKEN. FINALLY, HE CHANGED TO COMPETITOR'S PLASTIC STENT, THEN IT'S OKAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672610 ↗MalfunctionDec 1, 2025Failure to Advance; Failure to Advance
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-JAN-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689591 ↗MalfunctionApr 9, 2024Device Damaged Prior to Use; Dent in Material; Device Damaged Prior to Use; Dent in Material
A SLIGHT BENDING IS NOTICED AT ONE END OF THE PIGTAIL STENT UPON OPENING UP THE PACKAGING. RESISTANCE WAS FELT AND STUCKED AT THE BENDING PART WHILE INTRODUCING SOLUS INTRODUCER THROUGH THE DOUBLE PIGTAIL STENT. SECOND SET WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069228 ↗InjuryDec 15, 2023Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance
ON (B)(6) 2023 USER WAS CONDUCTING GASTROINTESTINAL ENDOSCOPY EXAMINATION AND TREATMENT. USER TOOK 10FR STENT WITH 3.7MM ENDOSCOPE TO CONDUCT BILE DRAINAGE ACCORDING TO IFU INSTRUCTION. DURING THE PROCEDURE, USER ADVANCED THE STENT INTO ENDOSCOPE WORKING CHANNEL SUCCESSFULLY , BUT CANNOT ADVANCED THE STENT THROUGH THE DISTAL END OF WORKING CHANNEL, AND THE STENT PUSHER WAS STUCK INSIDE THE ENDOSCOPE WORKING CHANNEL AND CANNOT MOVE FORWARD. USER HAS 2 CHOICES AT THE MOMENT, ONE IS CHANGE A SMALLER SIZE OF STENT (7FR), OR CHANGED A BIGGER DIAMETER ENDOSCOPE. BUT USER CONSIDER THE 3.7MM ENDOSCOPE IS MORE CONVENIENT TO PROCEED THE PROCEDURE, AND CHANGED ENDOSCOPE REQUIRES MORE TIME AND MORE COMPLICATED, USER DECIDED TO CHANGE THE SENT TO CONTINUE THE PROCEDURE. THIS KIND OF PROCEDURE NORMALLY COMPLETED IN 2 HOURS, BUT THIS PROCEDURE WAS COMPLETED USING 7 HOURS. USER OBSERVED THE PATIENT OUTCOME THROUGH THE PROCEDURE WHICH IS WELL. AND THE PATIENT RECOVERS WELL AFTER PROCEDURE, NO HARM TO PATIENT. USER REPORTED THE AE TO NATIONAL AE SYSTEM AS IT IS PROLONG THE PROCEDURE SERIOUSLY. PATIENT OUTCOME: THE PROCEDURE PROLONG 5 HOURS THAN USUAL. PATIENT IS WELL DURING PROCEDURE AND RECOVERS WE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335200 ↗MalfunctionJan 5, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
THE STENT VERY DIFFICULT TO LOAD INTO THE GUIDING CATHETER, AND DIFFICULT TO DEPLOY, THE GUIDING CATHETER HAS BEEN BROKEN BECAUSE FORCE TO DEPLOY. THE WHOLE SYSTEM HAS BEEN TAKEN OUT FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102040 ↗InjuryJun 23, 2022Migration; Migration
WHEN THE PHYSICIAN TRIED TO INSERT ZSS-10-12, HE COULDN¿T DEPLOY THIS STENT BECAUSE THE STENT MIGRATED VERY FAST. (USER ERROR: INCORRECT SIZE WIREGUIDE USED 0.025 INCH) SO REMOVED THE STENT AND USED 7FR DOUBLE-PIGTAIL STENT. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14787327 ↗MalfunctionJun 16, 2022Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
USER DETECTED THE PUSHER CANNOT BE PUT THROUGH STENT AT PREPARATION STAGE. NO USE ON PATIENT. N/A ¿ THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14712492 ↗MalfunctionApr 29, 2021Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking
THE INNER GUIDING CATHETER WAS NOT SEPARATED FROM THE PUSHING CATHETER(OUTER, COLOR IS PURPLE) WHEN THE STENT WAS TRIED TO BE PLACED IN THE BILE DUCT. THEY RE-STARTED STENT PLACED PROCEDURES, PLACED THE OTHER STENT ON THE BILE DUCT, AND FINISHED THE PROCEDURE. (THE STENT USED IS UNKNOWN). DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO. PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. THIS PRODUCT WAS LOCATED IN THE ERCP ROOM PRIOR TO USE. WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? VISIGLIDE 2 GUIDEWIRE - OUTER DIAMETER 0.025IN / LENGTH 450CM / TIP SHAPE ANGLED / FIRST USE. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. SPHINCTEROTOMY. WAS THE WIRE GUIDE INSPECTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11743758 ↗MalfunctionFeb 25, 2021Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11378767 ↗MalfunctionJan 13, 2021Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 11164179 ↗MalfunctionApr 7, 2020Difficult to Advance; Difficult to Advance
AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER WENT TO DEPLOY STENT, AND GUIDING CATHETER STRETCHED AND MADE DEPLOYMENT IMPOSSIBLE. THE WHITE HUB CAME OFF THE CATHETER WHEN THEY TRIED TO DEPLOY. CUSTOMER HAD TO REMOVE ALL OF PRODUCT/DELIVERY SYSTEM; THEY COMPLETED THE PROCEDURE SOMEHOW, BUT UNKNOWN WITH WHAT SORT OF DEVICE. NO ADDITIONAL PROCEDURES REQUIRED, NO ADVERSE EFFECTS EXPERIENCED BY PATIENT, NOTHING REMAINING IN PATIENT, NO PROLONGED HOSPITALIZATION." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THE EVENT? NO IF YES, PLEASE DESCRIBE. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9932697 ↗MalfunctionApr 6, 2020Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance
AS REPORTED TO CUSTOMER RELATIONS: "2 EA DEVICES, DURING THE SAME PROCEDURE, HAD THE SAME FAILURE MODE. BOTH MADE PATIENT CONTACT BUT ONLY 1 EA IS AVAILABLE FOR RETURN (OTHER THROWN AWAY). DM EVALUATION OF RETURNABLE PRODUCT IS THAT THE PUSHING CATHETER KINKED DURING STENT ADVANCEMENT, AND WHEN THEY WERE TRYING TO DEPLOY THE GUIDING CATHETER THE WHITE CAP CAME OFF. PROCEDURE WAS COMPLETED WITH UNKNOWN DEVICE. NO ADD'L PROCEDURES REQUIRED, NO ADVERSE EFFECTS EXPERIENCED BY PATIENT, NOTHING REMAINING IN PATIENT, NO PROLONGED HOSPITALIZATION." .1 FOR ALL COMPLAINTS, ASK: 2.1.1 DOES THE COMPLAINT RELATE TO: DEVICE PLACEMENT (THIS ONE). DEVICE REMOVAL. OBSERVATION PRIOR TO PATIENT CONTACT. 2.1.2 PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. IN THE BOX, IN THE PROCEDURE ROOM IN A CABINET. 2.1.3 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? UNKNOWN, EITHER .035 (BOSTON HYDROJAG) OR .025 (COOK). 2.1.4 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? ASKU. IF YES, PLEASE INDICATE THE PROCEDURE PERFORMED. 2.1.5 WAS THE WIRE GUIDE INS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929091 ↗MalfunctionFeb 21, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance
"PRODUCTS WOULDN'T WORK. ANY OF THE SOLUS DOUBLE PIGTAIL STENTS WITH INTRODUCERS WOULD NOT GO THROUGH THE WIRE LOCKS. "AS PER COMPLAINT FORM": WHEN TRYING TO USE THESE STENTS , THE STENT WOULD NOT FEED THROUGH THE WIRELOCK- IT WAS IMPOSSIBLE TO MOVE IT THROUGH AS THE STENT ISNT TAPPERED. WHEN WE REMOVED THE WIRELOCK IT WAS ALSO TOO DIFFICULT TO PUSH THE STENT INTO THE DUCT. FINISHED BY USING A 7FRENCH DOUBLE PIGTAIL STENT INSTEAD WHICH THE DOCTOR DIDNT WANT TO USE UNFORTUNATELY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9737896 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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