Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage
Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The source text does not report any injuries or illnesses.
Plain-English summary
Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic guidewire, a sterile medical device used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures. The recall is being conducted due to reports that the outer polymer jacket of the guidewire may be damaged during use.
The affected product is the HydroFinity Hydrophilic guidewire, Model HPSA35180, which features a 0.035 OD, stiff shaft, and angled tip with a length of 180 cm. The device was manufactured by NDC Inc. in Costa Rica for Covidien. The recall covers all lots of this specific model.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada. Users of this medical device should stop using the affected guidewires and contact the recalling firm for further instructions.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophi
- Manufacturer
- Nitinol Devices and Components, Inc.
- Hazard
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 (1)
- Model HPSA35180- all lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Nitinol Devices and Components, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Nitinol Devices and Components, Inc.
See all →- SevereNitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
- HighNitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
FDA (Devices) · 2014-07-02
- HighFDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
- HighNitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
FDA (Devices) · 2014-07-02
- HighNitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage
FDA (Devices) · 2014-07-02
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