Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket can 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 (jacket damage) that poses a risk of harm during use, but the source text does not report specific injuries or illnesses, 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 used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures. The recall involves Model HPSA35150 across all lots.
The recall was initiated due to reports that the outer polymer jacket of the guidewire was damaged during use. The affected products were distributed worldwide, including nationwide in the United States and internationally to Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada.
Healthcare professionals and facilities that have received these guidewires should stop using them and contact the recalling firm for further instructions. The source text does not specify the number of affected units, specific lot numbers, or reported injuries.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 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.
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 HPSA35150- 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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