FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
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 involves Model HPRA35150, all lots, with a total of 8,485 units distributed in the US and 9,595 units distributed internationally.
The recall was initiated due to reports of the outer polymer jacket to the core wire being damaged during use. The product was manufactured for Covidien in Plymouth, MN, and manufactured by NDC Inc. in Fremont, CA, with production in Costa Rica. Distribution was worldwide, including the United States and countries such as Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada.
Healthcare providers and facilities should stop using the affected guidewires and contact the recalling firm for further instructions. Consumers are not expected to have these devices in their homes, as they are professional medical devices used in clinical settings.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydro
- 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 HPRA35150 - 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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