HiWire G30481Recalls & reported problems
Cook Incorporated · HiWire Nitinol Core Wire Guide Angled with Hydrophilic Coating Standard Shaft and 3cm Flexible Tip · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002304819), received between Sep 14, 2017 and Jan 10, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated5
Patient problems
- No Consequences Or Impact To Patient4
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2024Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, DURING A MEDIPORT REPLACEMENT, A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE'S OUTER COATING CAME OFF AND WAS LEFT INSIDE THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 18489423 ↗MalfunctionDec 11, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PRIOR TO THE BEGINNING OF A URETEROSCOPY, THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS FOUND TO BE "DRY AND NOT SLIPPERY". THE OPERATOR THOUGHT THE COATING WAS SEPARATING FROM THE GUIDEWIRE AT "FIRST CONTACT." IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AND IF THAT INFORMATION IS RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9449873 ↗MalfunctionDec 10, 2019Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9446076 ↗MalfunctionDec 10, 2019Peeled/Delaminated; Peeled/Delaminated
NO ADDITIONAL PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9446018 ↗MalfunctionSep 14, 2017Peeled/Delaminated; Peeled/Delaminated
DURING AN UNSPECIFIED PROCEDURE, THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS USED AND IT WAS NOTED THAT THE GLIDE WIRE WAS STRIPPED. ANOTHER OF THE SAME WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. AS REPORTED NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6865230 ↗
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- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.