Roadrunner G09608Recalls & reported problems
Cook Incorporated · Roadrunner, PC Wire Guide Nimble, · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002096080), received between Sep 26, 2018 and Jun 4, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (3 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-1707-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Difficult to Advance3
- Break1
- Difficult to Remove1
- Material Split, Cut or Torn1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2024Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOUR ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES ¿BROKE AT THE DISTAL END DURING USE.¿ REPORTEDLY, THE WIRES BECAME PROGRESSIVELY ¿MORE DAMAGED¿ AT THE DISTAL END. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19463429 ↗MalfunctionMay 9, 2022Difficult to Advance; Difficult to Advance
AS REPORTED, DURING A PROCEDURE INVOLVING A THROMBECTOMY VIA RIGHT GROIN APPROACH, AN UNSPECIFIED SHEATH WOULD NOT ADVANCE OVER A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE. THE WIRE WAS REPLACED WITH AN UNKNOWN STIFF WIRE TO COMPLETE THE PROCEDURE. 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 14338345 ↗MalfunctionJan 27, 2022Difficult to Advance; Difficult to Advance
AS REPORTED, THIRTY ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13367772 ↗InjuryJan 27, 2022Difficult to Advance; Difficult to Advance
NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS REPORT WAS SUBMITTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13367686 ↗MalfunctionSep 26, 2018Difficult to Remove; Material Split, Cut or Torn
THE COMPLAINANT REPORTED THAT THE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE WOULD NOT COME OUT OF THE HOLDER, AND IT WAS SPLIT AFTER IT WAS FINALLY REMOVED. IT WAS FURTHER NOTED THAT A SECTION OF THE POLYMER MATERIAL WAS MISSING FROM THE DISTAL END OF THE WIRE WHICH RESULTED IN EXPOSURE OF THE INNER MANDRIL WIRE. THIS PRODUCT ISSUE OCCURRED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED IMPACT ON THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 7909524 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.