FanelliRecalls & reported problems across all models
Cook Incorporated · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 2 models of Fanelli by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Dec 23, 2016 and Jul 13, 2022 — classified as 8 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
Most reported Fanelli problems
Device problems
- Material Separation8
- Break4
- Fracture4
- Material Fragmentation4
- Detachment of Device or Device Component3
- Material Disintegration3
- Bent1
- Crack1
Patient problems
- No Patient Involvement12
- No Clinical Signs, Symptoms or Conditions5
- No Code Available5
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient3
- No Consequences Or Impact To Patient1
Fanelli models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fanelli G13699CATHETER, BILIARY, DIAGNOSTIC26 reports
- Fanelli G12950CATHETER, CHOLANGIOGRAPHY2 reports
Recent Fanelli adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Break; Break
IT WAS REPORTED THAT ON A ROUTINE CHECK, THREE FANELLI LAPAROSCOPIC ENDOBILIARY STENT SETS WERE FOUND TO BE BREAKING APART AT THE FLEXIBLE TIP. ALL PACKAGING WAS NOTED TO BE INTACT, UNDAMAGED AND WITHIN THE EXPIRATION DATE. NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15005876 ↗MalfunctionAug 19, 2021Fracture; Nonstandard Device; Failure to Eject; Fracture; Nonstandard Device; Failure to Eject
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12341703 ↗MalfunctionJun 2, 2021Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11922514 ↗MalfunctionApr 23, 2021Degraded; Material Fragmentation; Material Separation; Degraded; Material Fragmentation; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11716767 ↗MalfunctionDec 30, 2020Material Disintegration; Material Disintegration
IN ADDITIONAL INFORMATION RECEIVED ON 13JAN2021, IT WAS REPORTED THAT THE DEVICES WERE NOT STORED IN DIRECT SUNLIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11094892 ↗InjuryNov 5, 2020Material Disintegration; Material Disintegration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 10793815 ↗MalfunctionOct 8, 2020Material Disintegration; Material Disintegration
IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 08NOV2020 THAT THE DEVICE WAS STORED IN A STERILE STORE ROOM AREA AND NOT IN DIRECT LIGHT.
Patient problems: No Patient Involvement
MAUDE report 10648236 ↗MalfunctionJul 30, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10344521 ↗MalfunctionJul 30, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10344392 ↗MalfunctionJul 24, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8822995 ↗MalfunctionMar 22, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8445552 ↗MalfunctionFeb 27, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION HAS BEEN REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8374009 ↗InjuryFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT UNDERWENT A CHOLECYSTECTOMY VIA A LAPAROSCOPIC CHOLANGIOGRAPHY. DURING THE PROCEDURE, A FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET WAS USED AS THE CHOLANGIOGRAM "SHOWED INITIALLY A VERY SMALL AMOUNT OF CONTRAST GETTING INTO THE DUODENUM THEN OBSTRUCTION WITH A VISIBLE STONE". UNDER FLUOROSCOPY, AFTER THE CYSTIC DUCT INTRODUCER WAS REMOVED, THE STENT AND THE STENT DELIVERY SYSTEM WERE PASSED OVER THE GUIDE WIRE INTO THE CYSTIC DUCT AND ADVANCED THROUGH THE AMPULLA AND PART WAY INTO THE DUODENUM. THE RADIOPAQUE MARKINGS OF THE STENT DELIVERY SYSTEM SHOWED 2 IN THE COMMON BILE DUCT AND 2 IN THE DUODENUM. WHEN THE OUTER SLEEVE OF THE DELIVERY SYSTEM WAS RETRACTED TO DEPLOY THE STENT, RESISTANCE WAS ENCOUNTERED WHEN PULLING THE PROXIMAL PORTION OF THE DELIVERY SYSTEM BACK WITH THE GUIDE WIRE. AS A RESULT, THE WIRE WAS REMOVED AND THE DELIVERY SYSTEM COULD BE PULLED BACK WITH LITTLE OR NO RESISTANCE [SIC]. AS THE RADIOPAQUE MARKERS ON THE END OF THE DEVICE APPROACHED THE POSITION OF FINAL DEPLOYMENT, RESISTANCE WAS MET AGAIN. RETRACTION WAS CONTINUED. THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE 2 RADIOPAQUE MARKERS CAME OFF THE DELIVERY SYSTEM AND FELL INT
Patient problems: Foreign Body In Patient
MAUDE report 8297974 ↗InjuryDec 13, 2018Break; Break
ADDITIONAL INFORMATION RECEIVED ON 04MAR2019. THE PROCEDURE WAS SUCCESSFUL AND A SECOND STENT WAS USED AND PERFORMED PROPERLY. ALSO, THE PATIENT IS IN GOOD STATUS WITH NO PROBLEMS POST OPERATIVELY.
Patient problems: No Code Available
MAUDE report 8159548 ↗InjurySep 21, 2018Material Fragmentation; Material Fragmentation
ADDITIONAL INFORMATION WAS PROVIDED FROM THE FACILITY. THE DEVICE WAS INTRODUCED INTO THE COMMON BILE DUCT, HOWEVER, THE DOCTOR WAS UNSURE IF PROPER PLACEMENT WAS ACHIEVED. THE DEVICE WAS WITHDRAWN BY PULLING BACK COMPLETELY AND PART OF THE STENT REMAINED IN THE PATIENT AND THE ANOTHER PART REMAINED WITHIN THE MECHANISM. THE PATIENT HAD A SCHEDULED ERCP; THEREFORE, THIS WAS NOT AN ADDITIONAL PROCEDURE NOR DID IT REQUIRE ONE. THE PATIENT CURRENTLY HAS SHOWN NO COMPLICATIONS AND FRAGMENTS ARE BEING SENT TO COOK MEDICAL FOR EVALUATION. THE DEVICE WAS NOT EXPOSED TO NATURAL LIGHT AND KEPT IN A STORAGE ROOM WITH STANDARD FLURO TUBE LIGHTING SYSTEMS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7899023 ↗
Other Cook Incorporated products
All Cook Incorporated 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.
How reports and recalls are matched · Editorial policy · Report an error on this page