Fusion G31910Recalls & reported problems
Cook Incorporated · Fusion Ultra Short Wire Guide · Class 2
All models of Fusion (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002319103), received between Jun 4, 2019 and Jun 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2019Peeled/Delaminated; Peeled/Delaminated
DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION ULTRA SHORT WIRE GUIDE. A COMPLAINT FORM FOR MULTIPLE DEVICES WAS RECEIVED 05/08/2019 WITH A COOK FUSION ULTRA SHORT WIRE GUIDE LISTED. THERE WAS NO DESCRIPTION PROVIDED FOR THIS DEVICE, THEREFORE THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. A COOK FUSION ULTRA SHORT WIRE GUIDE WAS RECEIVED FOR EVALUATION ON 05/13/2019 AND FOUND TO HAVE COATING DAMAGE AT 5 - 6.2 CM WITH THE CORE WIRE EXPOSED. THERE WAS NO COMPLAINT REPORTED ON THE RETURNED WIRE GUIDE; HOWEVER, THE WIRE GUIDE WAS RETURNED WITH A BAG OF MULTIPLE OTHER DEVICES. THE DESCRIPTION OF EVENT FOR THE RELATED DEVICES [DIFFERENT REFERENCE PART NUMBERS] STATES THAT THE "COATING IN SOME CASES LOOSENS AND POSSIBLY MAKES ENTRY DIFFICULT [COATING DAMAGE], FOR EXAMPLE DURING STENT INTRODUCTION." THE RELATED MDRS WERE REPORTED UNDER 1037905-2019-00220 AND 1037905-2019-00221. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 THESE OCCURRENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8666725 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
- HiWire G30474Cook Incorporated · Endoscopic guidewire, gastroenterology-urology82 reports
- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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