Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.
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: The recall involves a medical device with a structural defect (damaged outer polymer jacket) that poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic guidewire, a sterile nitinol guidewire with a hydrophilic coating. The recall is due to reports that the outer polymer jacket to the core wire was damaged during use.
The affected product is the HydroFinity Hydrophilic guidewire, Model HPSS35150, all lots. The device is manufactured by NDC Inc. in Costa Rica for Covidien. It is used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures.
The recall covers 8,485 units in the US and 9,595 units internationally. Distribution was worldwide, including the US, Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada. Users should stop using the affected guidewires and contact the recalling firm for instructions.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
- Manufacturer
- Nitinol Devices and Components, Inc.
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 HPSS35150- 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 Polymer Jacket Damage
FDA (Devices) · 2014-07-02
- SevereFDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
FDA (Devices) · 2014-07-02
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