Roadrunner G07518Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide The Firm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002075184), received between Jan 26, 2018 and May 9, 2024 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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
- Jul 19, 2022Open, Classified
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Z-1709-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping4
- Contamination /Decontamination Problem3
- Material Separation1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 19278574 ↗MalfunctionMay 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 19278438 ↗MalfunctionMay 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT ONE UNIT OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS NOTED TO BE DIRTY UPON ARRIVAL AND INSPECTION AT THE DISTRIBUTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19272138 ↗MalfunctionMay 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY THE DISTRIBUTOR, TWO ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDES WERE FOUND TO HAVE "DIRTY GUIDEWIRES" WHEN THE PRODUCT ARRIVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271769 ↗MalfunctionApr 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY A DISTRIBUTOR, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN THE PACKAGES OF TWO ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDES. THERE WAS NO PATIENT INVOLVEMENT, AS THE FOREIGN MATTER WAS FOUND WHEN THE PRODUCTS ARRIVED AT THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19174244 ↗MalfunctionMay 29, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Patient Involvement
MAUDE report 10101464 ↗MalfunctionMay 4, 2020Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE TO REMOVE A CLOT, A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE PEELED. THE DEVICE WAS USED WITH AN UNKNOWN BALLOON. AFTER INFLATION, THE USER REMOVED THE BALLOON, AT WHICH POINT THE WIRE GUIDE'S "PEELING" CAME OUT WITH THE BALLOON. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10020766 ↗MalfunctionJul 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8768955 ↗InjuryJan 26, 2018Material Separation; Material Separation
IT WAS REPORTED THAT DURING ENDOVASCULAR SURGERY, THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE CAME OUT OF THE LUMEN OF ANOTHER MANUFACTURER'S 5 FR CATHETER. WHEN THE PHYSICIAN TRIED TO REPOSITION THE WIRE GUIDE, THE TIP WAS OBSERVED TO BE BROKEN. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AS THE LESION COULD NOT BE RE-CANALIZED AND THE BROKEN TIP PORTION REMAINED INSIDE OF THE PATIENT'S ANATOMY. A BY-PASS WAS PERFORMED AND THE TIP PORTION WAS UNABLE TO BE RETRIEVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7221917 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.