Roadrunner G18629Recalls & reported problems
Cook Incorporated · Roadrunner, Hydrophilic PC Wire Guide With Flexible Shaft and Short Taper · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002186293), received between Dec 11, 2018 and Jul 16, 2024 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (6 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
- Device Damaged Prior to Use6
- Break5
- Material Separation4
- Unraveled Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Material Separation; 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 19752264 ↗MalfunctionJun 3, 2024Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use
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 19446355 ↗MalfunctionMar 20, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
THE HOLDER WAS NOT FLUSHED PRIOR TO ATTEMPTING TO REMOVE THE WIRE GUIDE FROM THE HOLDER. THE PROCEDURE WAS COMPLETE BY USING ANOTHER WIRE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941994 ↗MalfunctionMar 20, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
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 18941815 ↗MalfunctionSep 25, 2023Material Separation; 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 17809371 ↗MalfunctionSep 22, 2023Break; Material Separation; Unraveled Material; Break; Material Separation; Unraveled Material
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 17799655 ↗MalfunctionJun 29, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17224711 ↗MalfunctionMay 18, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use
AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE, THE TIP OF ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE WAS SEPARATED. THE SEPARATED DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16955399 ↗InjuryJun 7, 2021Material Separation; Material Separation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11947571 ↗MalfunctionDec 11, 2018Device Damaged Prior to Use; Device Damaged Prior to Use
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8151752 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.