Roadrunner G07516Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide The Firm LT · Class 2
All models of Roadrunner (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002075160), received between Sep 20, 2018 and Dec 8, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1708-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping7
- Material Fragmentation1
- Peeled/Delaminated1
- Physical Resistance/Sticking1
- Tear, Rip or Hole in Device Packaging1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY A DISTRIBUTOR, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE'S STERILE PACKAGE. BECAUSE THIS WAS NOTED WITHIN A DISTRIBUTION FACILITY, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741059 ↗MalfunctionDec 5, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 23729588 ↗MalfunctionDec 5, 2025Device 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 23729104 ↗MalfunctionSep 12, 2023Device 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 17728621 ↗MalfunctionSep 12, 2023Device 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 17728613 ↗MalfunctionSep 12, 2023Device 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 17728438 ↗MalfunctionSep 12, 2023Device 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 17728235 ↗MalfunctionAug 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, UPON ARRIVAL AT THE DISTRIBUTION CENTER, TWO ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDES HAD A HAIR LIKE FIBER IN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17646193 ↗MalfunctionJul 14, 2023Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material
ADDITIONAL INFORMATION WAS RECEIVED 10OCT2023. THE COATING DID NOT PEEL FROM THE DEVICE. THE WIRE/COILS UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17326102 ↗MalfunctionSep 20, 2018Material Fragmentation; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PHYSICIAN FELT RESISTANCE WHEN REMOVING THE ROADRUNNER GUIDE WIRE FROM THE HOLDER, AND THAT THERE WERE DARK SPOTS INSIDE THE WIRE HOLDER. IT DID NOT MAKE PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, SO THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THE PRESENCE OF DARK SPOTS AND SHEARING DAMAGE TO THE WIRE¿S POLYMER COATING.
Patient problems: No Information
MAUDE report 7895243 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- 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 · each recall links to the FDA recall notice
- 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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