Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure
Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a high-risk sterile medical device with potential sterility compromise. No illnesses or injuries have been reported, and the hazard remains theoretical based on failed packaging testing. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Cook Incorporated is recalling 1,450 units of the Roadrunner PC Hydrophilic Wire Guide (Reference Part Number RLPC-35-180, Order Number G07516). This medical device is used for vascular catheter positioning and exchange in diagnostic and interventional procedures.
The devices did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing. As a result, the sterility of the devices may be compromised, which could pose a risk to patients undergoing vascular procedures.
The affected devices were distributed nationwide and internationally. Affected lot numbers include 14103953, 14103956, 14143728, 14145412, 14145419, 14153927, 14156907, 14156908, 14156914, and 14160996.
Healthcare providers and patients should contact Cook Incorporated for instructions regarding device return or replacement.
The recalled product
- Product
- Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- UDI-DI: (01)00827002075160- Lot Numbers: 14103953
- 14103956
- 14143728
- 14145412
- 14145419
- 14153927
- 14156907
- 14156908
- 14156914
- 14160996
Distribution
Distributed nationwide across the United States.
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