Roadrunner G17539Recalls & reported problems
Cook Incorporated · Roadrunner, Hydrophilic PC Wire Guide With Flexible Shaft And Short Taper · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002175396), received between Oct 1, 2019 and Jan 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1837-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Unraveled Material
IT WAS REPORTED, THE 'ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE' CAME OUT OF ITS SILICONE PACKAGING. THE PRODUCT WAS REPLACED BEFORE THE PROCEDURE BEGAN. THE DEVICE WAS RETURNED 08JAN2026 AND THE PRELIMINARY DFA FOUND THE WIRE GUIDE WAS SEPARATED. THE OUTER COATING WAS COMPLETELY BROKEN, AND THE INNER COIL WAS EXPOSED. 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 24203137 ↗MalfunctionOct 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION SINCE LAST REPORT WAS SUBMITTED ON 01OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141221 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
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- 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 G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
- Acrobat G34266Cook Incorporated · Endoscopic guidewire, gastroenterology-urology44 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.