Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewires because reports indicate 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 (jacket damage) that poses a risk of harm during use, but the source text does not report any 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. The specific model involved is HPRA35260, which features a 0.035 OD, standard shaft, angled tip, and 260 cm length. The device is manufactured for Covidien in Plymouth, MN, and by NDC Inc. in Fremont, CA, with production in Costa Rica.
The recall was initiated due to reports that the outer polymer jacket of the guidewire was damaged to the core wire during use. The guidewire is used to facilitate the introduction and placement of catheters and interventional devices to desired anatomical locations during diagnostic or interventional procedures.
The recall affects 8,485 units in the United States and 9,595 units distributed internationally, with a total of 18,080 units worldwide. Distribution was nationwide in the US and internationally to Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada. All lots of model HPRA35260 are included in this recall.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrop
- 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 HPRA35260- 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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