Roadrunner G18155Recalls & reported problems
Cook Incorporated · Roadrunner, Hydrophilic PC Wire Guide With 8cm Taper · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002181557), received between Jul 31, 2020 and Dec 5, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).
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
- Peeled/Delaminated2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE HYDROPHILIC COATING HAD PEELED OFF OF A 'ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE'. THIS WAS IDENTIFIED BY THE USER PRIOR TO PATIENT CONTACT WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE WIRE GUIDE HOLDER. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. 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 18266157 ↗MalfunctionJan 4, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, PARTS OF THE COATING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE SEPARATED FROM THE DEVICE. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THERE WERE NO ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED DUE TO THIS EVENT. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13151330 ↗MalfunctionJul 31, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Patient Involvement
MAUDE report 10349471 ↗
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 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
- 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.