Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
HydroFinity Hydrophilic guidewire Recalled by Nitinol Devices and Components, Inc. Due to Reports of outer polymer jacket to the core...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nitinol Devices and Components, Inc. directly.
Affected Products
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Quantity: 8485 in US, 9595 - ROW - total, all models
Why Was This Recalled?
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nitinol Devices and Components, Inc.
Nitinol Devices and Components, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report