Roadrunner G07937Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide Nimble, Floppy · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002079373), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flaked” (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.
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-1706-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Flaked1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2023Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated
AS REPORTED, DURING AN ANGIOGRAM, A ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE WAS STICKY AND GOT STUCK IN AN UNSPECIFIED CATHETER. LATEX GLOVES WERE WORN AND THE COATING WAS ACTIVATED WITH SALINE. THE WIRE FELT "RUFFLED" AND WHITE MATERIAL WAS FLAKING OFF THE WIRE, HOWEVER, THE USER IS UNSURE IF THE INNER WIRE WAS EXPOSED. THE FLAKING WAS NOTED WHEN FLUSHING THE WIRE AND ACTIVATION WENT "QUICKLY". THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479402 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.