RoadrunnerRecalls & reported problems across all models
Cook Incorporated · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
9 open recalls name at least one Roadrunner model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 183
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 9
We found 28 models of Roadrunner by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2016 and Sep 30, 2026 — classified as 18 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (49 reports).
9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Roadrunner recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1841-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1840-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1839-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1838-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1837-2022 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
- 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 ↗
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Roadrunner problems
Device problems
- Device Contaminated During Manufacture or Shipping49
- Material Separation23
- Contamination /Decontamination Problem19
- Peeled/Delaminated19
- Unraveled Material19
- Break18
- Tear, Rip or Hole in Device Packaging12
- Device Damaged Prior to Use7
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- No Patient Involvement19
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient13
- Foreign Body In Patient7
- Internal Organ Perforation4
- No Code Available4
- Device Embedded In Tissue or Plaque3
Roadrunner models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Roadrunner G06866WIRE, GUIDE, CATHETER1 recall29 reports
- Roadrunner G18154Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G07516WIRE, GUIDE, CATHETER1 recall10 reports
- Roadrunner G07518WIRE, GUIDE, CATHETER1 recall9 reports
- Roadrunner G17542Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G09607WIRE, GUIDE, CATHETER1 recall6 reports
- Roadrunner G18153Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G09608WIRE, GUIDE, CATHETER1 recall5 reports
- Roadrunner G06979WIRE, GUIDE, CATHETER1 recall3 reports
- Roadrunner G18155Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G07937WIRE, GUIDE, CATHETER1 recall1 report
- Roadrunner G07914WIRE, GUIDE, CATHETER1 recall0 reports
- Roadrunner G09534WIRE, GUIDE, CATHETER1 recall0 reports
- Roadrunner G17540Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Roadrunner G09105WIRE, GUIDE, CATHETER33 reports
- Roadrunner G08801WIRE, GUIDE, CATHETER13 reports
- Roadrunner G18629Endoscopic guidewire, gastroenterology-urology10 reports
- Roadrunner G07640WIRE, GUIDE, CATHETER6 reports
- Roadrunner G09535WIRE, GUIDE, CATHETER6 reports
- Roadrunner G09609WIRE, GUIDE, CATHETER4 reports
- Roadrunner G09029WIRE, GUIDE, CATHETER3 reports
- Roadrunner G22416Endoscopic guidewire, gastroenterology-urology2 reports
- Roadrunner G11666WIRE, GUIDE, CATHETER1 report
- Roadrunner G12760WIRE, GUIDE, CATHETER1 report
- Roadrunner G18792Endoscopic guidewire, gastroenterology-urology1 report
- Roadrunner G22419Endoscopic guidewire, gastroenterology-urology1 report
- Roadrunner G23038Endoscopic guidewire, gastroenterology-urology1 report
Recent Roadrunner adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954661 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50297681 ↗MalfunctionJan 28, 2026Unraveled Material
IT WAS REPORTED, THE 'ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE' CAME OUT OF ITS SILICONE PACKAGING. THE PRODUCT WAS REPLACED BEFORE THE PROCEDURE BEGAN. THE DEVICE WAS RETURNED 08JAN2026 AND THE PRELIMINARY DFA FOUND THE WIRE GUIDE WAS SEPARATED. THE OUTER COATING WAS COMPLETELY BROKEN, AND THE INNER COIL WAS EXPOSED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203137 ↗MalfunctionDec 15, 2025Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed 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 23804397 ↗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, 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 23729701 ↗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 ↗MalfunctionNov 21, 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 23622086 ↗MalfunctionNov 21, 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 23622042 ↗MalfunctionNov 21, 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 23622009 ↗MalfunctionNov 21, 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 23621917 ↗MalfunctionNov 21, 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 23619388 ↗MalfunctionNov 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, TWO UNITS OF THE ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE WERE "NOT CLEAN". THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597912 ↗InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 23597379 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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