Roadrunner G09609Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide Nimble, · Class 2
All models of Roadrunner (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002096097), received between Mar 20, 2020 and Jun 2, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
- Tear, Rip or Hole in Device Packaging2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, FOREIGN MATTER RESEMBLING A "SMALL BEARING" OR "TINY BURN MARK" WAS NOTED IN A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S SEALED STERILE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122089 ↗MalfunctionMar 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY A DISTRIBUTOR, A SMALL HOLE WAS NOTED IN A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S STERILE PACKAGE. THE SHIPPING BOX WAS NOT DAMAGED; HOWEVER, THE REPORTER BELIEVES THAT THE PACKAGE DAMAGE RESULTED FROM THE WAY THE DEVICES WERE PACKAGED IN THE SHIPPING BOX. BECAUSE THE HOLE WAS NOTED UPON ARRIVAL TO THE DISTRIBUTION FACILITY, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584638 ↗MalfunctionJul 13, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED, UPON ARRIVAL TO A DISTRIBUTION FACILITY, A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S PACKAGE WAS FOUND TO BE PERFORATED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A SMALL HOLE/TEAR IN THE FRONT OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17318213 ↗MalfunctionMar 20, 2020Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; 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 Patient Involvement
MAUDE report 9860519 ↗
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- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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