HiWireRecalls & reported problems across all models
Cook Incorporated · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 16 models of HiWire by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2014 and Sep 3, 2026 — classified as 26 injuries, 115 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (77 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 HiWire problems
Device problems
- Peeled/Delaminated77
- Material Separation38
- Break16
- Device Damaged by Another Device4
- Difficult to Remove3
- Flaked3
- Difficult to Advance2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Consequences Or Impact To Patient39
- Foreign Body In Patient15
- No Known Impact Or Consequence To Patient10
- Insufficient Information6
- Device Embedded In Tissue or Plaque5
- No Code Available5
- Blood Loss1
HiWire models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HiWire G30474Endoscopic guidewire, gastroenterology-urology82 reports
- HiWire G30473Endoscopic guidewire, gastroenterology-urology12 reports
- HiWire G30475Endoscopic guidewire, gastroenterology-urology8 reports
- HiWire G30476Endoscopic guidewire, gastroenterology-urology8 reports
- HiWire G36282WIRE, GUIDE, CATHETER8 reports
- HiWire G30481Endoscopic guidewire, gastroenterology-urology5 reports
- HiWire G36293WIRE, GUIDE, CATHETER4 reports
- HiWire G30470Endoscopic guidewire, gastroenterology-urology3 reports
- HiWire G30477Endoscopic guidewire, gastroenterology-urology2 reports
- HiWire G36292WIRE, GUIDE, CATHETER2 reports
- HiWire G36300WIRE, GUIDE, CATHETER2 reports
- HiWire G30472Endoscopic guidewire, gastroenterology-urology1 report
- HiWire G36277WIRE, GUIDE, CATHETER1 report
- HiWire G36283WIRE, GUIDE, CATHETER1 report
- HiWire G36284WIRE, GUIDE, CATHETER1 report
- HiWire G36290WIRE, GUIDE, CATHETER1 report
Recent HiWire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Break
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50590561 ↗MalfunctionMay 27, 2026Peeled/Delaminated
IT WAS REPORTED THE JACKET IS SEPARATED IN THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. THE ISSUE WAS FOUND BY SUPPLIER DURING REVIEW OF DEVICE RETURNED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306281 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THE DISTAL END OF HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS BROKEN PRIOR TO USE IN THE URETERAL STONE PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 24741608 ↗MalfunctionMar 19, 2026Break
UPON OPENING THE DEVICE PACKAGING, IT WAS REPORTED THAT THE DISTAL END OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS OBSERVED TO BE BROKEN PRIOR TO USE IN A URETERAL STONE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640727 ↗MalfunctionFeb 26, 2026Peeled/Delaminated
IT WAS REPORTED, THE COATING OF THE DISTAL END OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDEWIRE GUIDE PEELED OFF. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER SAME TYPE 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 24456157 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE BROKE PRIOR TO A URETERAL STONE REMOVAL PROCEDURE. THE ISSUE WAS FOUND WHEN THE PACKAGE WAS OPENED AND AFTER REMOVING THE GUIDEWIRE A SMALL BLACK BROKEN FRAGMENT WAS FOUND IN THE POUCH. THE GUIDEWIRE DID NOT REMOVE FROM THE HOLDER AND WAS THE COATING ACTIVATED WITH SALINE SOLUTION. 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 24208784 ↗MalfunctionDec 4, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS ORIGINALLY REPORTED THAT AFTER INSERTION INTO THE PATIENT DURING A URETEROSCOPIC LITHOTOMY FOR KIDNEY STONE REMOVAL, THE USER FOUND THE TIP OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS "UNEVEN". RESISTANCE WAS FELT, "IN AND OUT". THE PROCEDURE WAS COMPLETED BY USING A NEW UNSPECIFIED WIRE GUIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THAT THE POLYMER JACKET HAD SEPARATED FROM THE WIRE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716972 ↗MalfunctionOct 20, 2025Material Separation; Material Separation
IT WAS REPORTED THAT PRIOR TO USE, THE COATING SEPARATED FROM THE INNER CORE AT THE DISTAL END OF THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE. THE USER REMOVED THE DEVICE FROM THE INTACT PACKAGE AND OBSERVED THE COATING AT THE DISTAL END OF THE WIRE GUIDE WAS DAMAGED. PER PROVIDED IMAGE, THE COATING WAS OBSERVED TO BE SEPARATED FROM THE INNER CORE OF THE WIRE GUIDE. 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 23335894 ↗MalfunctionOct 10, 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 23270705 ↗MalfunctionAug 18, 2025Peeled/Delaminated; Peeled/Delaminated
AS ORIGINALLY REPORTED, THE USER CONFIRMED THAT THE PACKAGE OF A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE DEVICE WAS INTACT BEFORE OPENING IT. THE DEVICE WAS REMOVED FROM THE PACKAGE AND SUBMERGED IN STERILE SALINE TO ACTIVATE THE COATING. DURING THE UNSPECIFIED PROCEDURE, THE WIRE GUIDE WAS REMOVED FROM ITS HOLDER AND WAS OBSERVED TO HAVE AN UNEVEN TWISTED APPEARANCE. THE USER REPLACED THE WIRE GUIDE WITH A NEW ONE TO CONTINUE THE PROCEDURE. THE OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON 01JUN2025. THE DEVICE WAS THEN SENT TO THE SUPPLIER FOR A SUPPLIER INVESTIGATION. ACCORDING TO THE SUPPLIER INVESTIGATION ON 24JUL2025, THE POLYMER JACKET OF THE WIRE GUIDE HAD SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22833890 ↗MalfunctionAug 12, 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 22781945 ↗MalfunctionJun 23, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED DURING A URETEROSCOPY LITHOTOMY WITH STONE REMOVAL PROCEDURE; THE USER ADVANCED THE SOFT ENDOSCOPE THROUGH WIRE GUIDE AND FOUND THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE COATING PEELED OFF. THE WIRE GUIDE COATING WAS ACTIVATED WITH SALINE. THERE WAS NO RESISTANCE WHEN ADVANCING THE ENDOSCOPE. A NEW GUIDEWIRE WAS REPLACED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 22309628 ↗InjuryMay 19, 2025Break; Break
IT WAS REPORTED; THE PATIENT UNDERWENT A LITHOTRIPSY AND STONE REMOVAL PROCEDURE IN (B)(6) 2025. THE PATIENT HAD A LARGE, COMPLETELY "CAST STONE" AND HEAVY STONE BURDEN IN THE RIGHT KIDNEY. IN (B)(6) 2025, DURING A FOLLOW UP APPOINTMENT AT A DIFFERENT FACILITY THAN WHERE THE LITHOTRIPSY AND STONE REMOVAL PROCEDURE HAD TAKEN PLACE, A 3 -5CM LONG PIECE OF METAL WAS DISCOVERED IN THE PATIENT'S RIGHT RENAL PARENCHYMA. THE METAL PIECE IS BELIEVED TO BE FROM THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE THAT WAS USED IN THE LITHOTRIPSY AND STONE REMOVAL PROCEDURE IN (B)(6) 2025. THE FOREIGN BODY REMAINS IN THE PATIENT, NO ADDITIONAL PROCEDURE IS CURRENTLY SCHEDULED TO REMOVE THE FOREIGN BODY, NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 22047692 ↗MalfunctionMay 8, 2025Material Separation; Material Separation
IT WAS REPORTED PRIOR TO PATIENT CONTACT; THE WIRE GUIDE COATING WAS ACTIVATED PRIOR TO REMOVAL FROM THE HOLDER BY INJECTING SALINE SOLUTION AND WAITING FOR 1 MINUTE. THE USER FELT THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE LUBRICATION WAS NOT ENOUGH AND WITH BURRS. THE BURR DID NOT DAMAGE THE SURFACE OF THE WIRE GUIDE. THE USER CHANGED TO ANOTHER SAME TYPE DEVICE 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21989095 ↗MalfunctionMar 6, 2025Material Separation; Material Separation
DURING A URETERAL CALCULI REMOVAL PROCEDURE, IT WAS REPORTED THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S TIP WAS NOTED TO BE FRACTURED UPON OPENING THE PACKAGE. THE WIRE GUIDE WAS ACTIVATED WITH SALINE AND WAS REMOVED FROM THE HOLDER AFTER SALINE INJECTION AT THE HOSPITAL. 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. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537257 ↗
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.
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