ZimmonRecalls & reported problems across all models
Cook Ireland Ltd · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 274
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 43 models of Zimmon by Cook Ireland Ltd in the FDA's device registry (GUDID). Together they are named in 274 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2017 and Oct 29, 2025 — classified as 15 injuries, 259 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (148 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 Zimmon problems
Device problems
- Material Deformation148
- Kinked45
- Difficult to Advance27
- Dent in Material25
- Material Twisted/Bent23
- Break12
- Migration or Expulsion of Device10
- Fracture9
Patient problems
- No Known Impact Or Consequence To Patient195
- No Consequences Or Impact To Patient38
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement8
- No Code Available7
- Foreign Body In Patient5
- Jaundice1
- Tissue Damage1
Zimmon models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zimmon G21396CATHETER, BILIARY, DIAGNOSTIC52 reports
- Zimmon G25794CATHETER, BILIARY, DIAGNOSTIC31 reports
- Zimmon G22167CATHETER, BILIARY, DIAGNOSTIC29 reports
- Zimmon G21393CATHETER, BILIARY, DIAGNOSTIC24 reports
- Zimmon G21708CATHETER, BILIARY, DIAGNOSTIC19 reports
- Zimmon G21707CATHETER, BILIARY, DIAGNOSTIC15 reports
- Zimmon G22163CATHETER, BILIARY, DIAGNOSTIC12 reports
- Zimmon G21711CATHETER, BILIARY, DIAGNOSTIC9 reports
- Zimmon G22161CATHETER, BILIARY, DIAGNOSTIC9 reports
- Zimmon G22170CATHETER, BILIARY, DIAGNOSTIC9 reports
- Zimmon G22980CATHETER, BILIARY, DIAGNOSTIC7 reports
- Zimmon G21526CATHETER, BILIARY, DIAGNOSTIC6 reports
- Zimmon G21637CATHETER, BILIARY, DIAGNOSTIC5 reports
- Zimmon G22164CATHETER, BILIARY, DIAGNOSTIC5 reports
- Zimmon G22979CATHETER, BILIARY, DIAGNOSTIC4 reports
- Zimmon G21369CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zimmon G22122CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zimmon G22159CATHETER, BILIARY, DIAGNOSTIC3 reports
- Zimmon G21460CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zimmon G21529CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zimmon G21640CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zimmon G22456CATHETER, BILIARY, DIAGNOSTIC2 reports
- Zimmon G21394CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21404CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21426CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21462CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21781CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21795CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21974CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21975CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G21982CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22026CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22137CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22353CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22354CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22355CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22362CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22455CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22978CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G22983CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G24567CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G24591CATHETER, BILIARY, DIAGNOSTIC1 report
- Zimmon G24592CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Zimmon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-DEC-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421030 ↗MalfunctionOct 28, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 10 DEC 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401789 ↗MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent
DESCRIPTION OF EVENT UNABLE TO THREAD THE GUIDEWIRE THROUGH THE STENT AS THE STENT¿S MATERIAL FELT STIFFER THAN USUAL. HOWEVER, ANOTHER IDENTICAL STENT WAS USED WITHOUT ANY DIFFICULTIES. PATIENT/EVENT INFORMATION: NOTES: THE FOLLOWING INFORMATION WAS RECEIVED ON 13OCT2025: WHAT WAS THE SIZE OF THE WIREGUIDE USED IN THE PREPARATION STAGES? 0.035 JAG (BOSTON). PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED IN 25 DEGREE CELSIUS ROOM. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 5 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? INSPECTED AND NO DEFECTS. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS TJF 160. ADDITIONAL FEEDBACK BY THE USER: "HE DOES FIND THAT ZEBD IS A BIT TOO STIFF IN GENERAL AND THIS PARTICULAR CASE, HE WAS SURPRISED HE HAD TROUBLE USING IT COS IT WAS STIFFER THAN HIS PAST EXPERIENCES WITH THE PRODUCT". ADDI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23401697 ↗MalfunctionOct 27, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON .01-DEC-2025. 08OCT2025 ADDITIONAL INFORMATION WAS OBTAINED. 1. WHAT WAS THE SIZE OF THE WIREGUIDE USED IN THE PREPARATION STAGES? 0.035 OR 0.025 2. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ON A SHELF IN A ROOM THAT IS NOT EXPOSED TO LIGHT. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NI. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NI. 6. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO. 7. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLYMPUS/JF260V.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391344 ↗MalfunctionOct 10, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-NOV-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270859 ↗MalfunctionOct 10, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270821 ↗MalfunctionOct 10, 2025Improper or Incorrect Procedure or Method; Dent in Material; Improper or Incorrect Procedure or Method; Dent in Material
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-NOV-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23270774 ↗MalfunctionSep 30, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-NOV-2025. ADDITIONAL INFORMATION RECEIVED - 01 OCT 2025 1. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORED ON A SHELF IN THE ENDOSCOPY ROOM AT ROOM TEMPERATURE. 2. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS, VISIGLIDE2, OD: 0.63MM. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NO. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO. 6. WERE PREVIOUS PROCEDURES I.E., SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? NI. 7. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NI. 8. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE? NO. 9. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? NI. 10. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NI 11. WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23178713 ↗MalfunctionSep 22, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-OCT-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23118962 ↗MalfunctionSep 22, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-OCT-2025. ADDITIONAL INFO RECEIVED ON 14-OCT-2025. 1. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. - HE KEPT THE ERCP ROOM SHADED STORAGE BOX. 2. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? - 0.025INCH / 450CM. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23109700 ↗MalfunctionSep 18, 2025Material Twisted/Bent; Material Twisted/Bent
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 04-NOV-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085579 ↗MalfunctionSep 18, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
THE DOCTOR WANTED TO INSERT ZSO-7-12 INTO THE CBD THROUGH THE PREPOSITIONED (VISIGLIDE 2 0.025 STRAIGHT) WIRE GUIDE, ASSISTANT NURSE TRIED TO STRAIGHTEN THE ZSO-7-12 USING A STRAIGHTENER. THE NURSE STRAIGHTENED ZSO'S PIGTAIL AND PASSED A WIRE THROUGH, BUT THE WIRE DID NOT PASS. THE WIRE DID NOT PASS BECAUSE THE PIGTAIL WAS BENT. THE NEW ZSO-7-12 WAS USED .AND WIRE GUIDE WAS NOT CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23080929 ↗MalfunctionSep 17, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
WHEN THE NURSE USED THE STRAIGHTENER TO STRAIGHTEN THE STENT, THE STENT WAS KINK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076156 ↗MalfunctionSep 9, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
AFTER PLACING A GUIDEWIRE (BOSTON SCIENTIFIC/ENDOSELECTOR 0.025 INCH) IN THE PANCREATIC DUCT, WHEN ADVANCING A STENT OVER THE GUIDEWIRE, THE GUIDEWIRE DID NOT EXIT THE GUIDEWIRE LUMEN OF THE STENT BUT INSTEAD EXITED THE GUTTER, MAKING IT UNUSABLE. THE PROCEDURE CONTINUED USING A DIFFERENT MODEL GEPD (DETAIL UNKNOWN). THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. NO HEALTH HAZARD. 1.DOES THE COMPLAINT RELATE TO: DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT DURING ADVANCING OVER A WIRE GUIDE. 2 WHAT WAS THE TARGET LOCATION FOR THE STENT? THE PANCREATIC DUCT. 3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. 4 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? BOSTON SCIENTIFIC/ENDOSELECTOR 0.025INCH. 5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES. 7 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? UNKNOWN. 10 DID
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004331 ↗MalfunctionAug 26, 2025Dent in Material; Material Twisted/Bent; Dent in Material; Material Twisted/Bent
THE DOCTOR WANTED TO INSERT ZSO-7-12 INTO THE CBD THROUGH THE PREPOSITIONED (VISIGLIDE 2 0.025 STRAIGHT) WIRE GUIDE, ASSISTANT NURSE TRIED TO STRAIGHTEN THE ZSO-7-12 USING A STRAIGHTENER. THE NURSE STRAIGHTENED ZSO'S PIGTAIL AND PASSED A WIRE THROUGH, BUT THE WIRE DID NOT PASS. THE WIRE DID NOT PASS BECAUSE THE PIGTAIL WAS BENT. THE NEW ZSO-7-12 WAS USED AND WIRE GUIDE WAS NOT CHANGED..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893824 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page