BiWireRecalls & reported problems across all models
Cook Incorporated · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of BiWire 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 Apr 8, 2016 and Jun 18, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (16 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 BiWire problems
Device problems
- Peeled/Delaminated16
- Material Separation9
- Unsealed Device Packaging3
- Break2
- Device Contaminated During Manufacture or Shipping1
- Difficult to Advance1
- Difficult to Remove1
- Inadequate Lubrication1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Foreign Body In Patient1
- No Code Available1
- No Known Impact Or Consequence To Patient1
BiWire models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BiWire G46138Endoscopic guidewire, gastroenterology-urology24 reports
- BiWire G46141Endoscopic guidewire, gastroenterology-urology3 reports
- BiWire G46139Endoscopic guidewire, gastroenterology-urology1 report
Recent BiWire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Peeled/Delaminated
IT WAS REPORTED PRIOR TO A BILATERAL URETEROSCOPIC EXAMINATION WITH STENT PLACEMENT, THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE COULD NOT BE ADVANCED THROUGH THE URETEROSCOPE AND "NODULES" WERE FOUND ON THE GUIDEWIRE. THE COATING OF THE WIRE GUIDE WAS NOT ACTIVATED PRIOR TO REMOVING FROM THE HOLDER. THE DEVICE WAS NOT USED AND THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. A PRELIMINARY REVIEW OF THE RETURNED DEVICE SHOWED AREAS OF SKIVED/CUT DAMAGE TO THE POLYMER JACKET MATERIAL, INCLUDING METALLIC CORE WIRE EXPOSURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545659 ↗MalfunctionMar 31, 2026Peeled/Delaminated
AS REPORTED, A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS USED DURING A URETER PROCEDURE TO FACILITATE THE PLACEMENT OF A STENT AFTER CRUSHING THE STONES. IT WAS OBSERVED THAT THE END OF THE WIRE GUIDE HAD A PROTRUSION RESEMBLING A WELDING POINT, WHICH PREVENTED THE STENT FROM PASSING THROUGH THE DEVICE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE. SUBSEQUENTLY, A DIFFERENT WIRE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COATING ON THE DEVICE WAS ACTIVATED PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER, WHICH WAS DONE BY INJECTING WATER INTO THE WIRE GUIDE HOLDER. THE DEVICE WAS USED IN CONJUNCTION WITH AN UNSPECIFIED SHEATH AND AN UNSPECIFIED STENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AN INVESTIGATION BY THE SUPPLIER REVEALED THAT THE COMPLAINT DEVICE EXHIBITED MULTIPLE AREAS OF SKIVED OR CUT DAMAGE TO THE POLYMER JACKET MATERIAL, ALONG WITH POLYMER JACKET MATERIAL DISPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743570 ↗MalfunctionMar 30, 2026Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730036 ↗MalfunctionDec 22, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865010 ↗MalfunctionDec 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT BEFORE A KIDNEY STONE PROCEDURE, THE OUTER STERILE PACKAGING OF THE 'BIWIRE NITINOL HYDROPHILIC WIRE GUIDE' SHOWED NO VISIBLE DAMAGE. HOWEVER, ONCE OPENED, THE INNER POUCH WAS FOUND PARTIALLY UNSEALED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. THE PROVIDED PHOTO SHOWS THE POUCH SEAL OPEN, WITH SEAL IMPRESSIONS VISIBLE ON THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708529 ↗MalfunctionOct 21, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE BROKE DURING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351363 ↗MalfunctionSep 23, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23125030 ↗MalfunctionAug 21, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS NOT SEALED. AFTER OPENING THE OUTER PACKAGING, THE USER OBSERVED THE INNER PACKAGING OF THE DEVICE WAS NOT SEALED. THE USER WAS CONCERNED THE DEVICE WAS CONTAMINATED; THEREFORE, ANOTHER SAME-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862638 ↗MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED 13OCT2025. NONE OF THE COATING HAD TO BE REMOVED FROM THE PATIENT. THE SCOPE WAS CHECKED FOR DAMAGE AND NO DAMAGE WAS OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808904 ↗MalfunctionMay 1, 2025Material Separation; Material Separation
IT WAS REPORTED A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE¿S TIP WAS FOUND BROKEN PRIOR TO USE IN A FLEXIBLE URETEROSCOPY PROCEDURE. THE ISSUE WAS FOUND UPON OPENING THE PACKAGE PRIOR TO ESTABLISHING PASSAGE UNDER THE UTEROSCOPE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PHOTO APPEARS TO SHOW THE POLYMER JACKET SEPARATED ON THE TIP. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21943215 ↗MalfunctionJan 21, 2025Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196722 ↗MalfunctionSep 17, 2024Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243082 ↗MalfunctionSep 13, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212883 ↗MalfunctionAug 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE 'BIWIRE NITINOL HYDROPHILIC WIRE GUIDES' STERILIZATION PACKAGE CONTAINED A BLACK FOREIGN SUBSTANCE UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076535 ↗MalfunctionJul 10, 2024Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
IT WAS REPORTED THE BIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S COATING WAS PEELED OFF PRIOR TO AN UNSPECIFIED PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711451 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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