FDA Recalls HydroFinity Hydrophilic Guidewires Due to 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
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 criteria for a High severity score.
Plain-English summary
Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic Guidewire, a sterile nitinol guidewire with a hydrophilic coating. The recall involves model HPSS35260 across all lots. The product is manufactured in Costa Rica for Covidien and distributed worldwide, including in the United States, Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada.
The recall was initiated due to reports that the outer polymer jacket of the guidewire may become damaged during use. This product is used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures.
Healthcare providers and facilities should stop using the affected guidewires and contact Nitinol Devices and Components, Inc. for further instructions on the recall.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity Hydr
- 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 HPSS35260- 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
- 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
- SevereFDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
FDA (Devices) · 2014-07-02
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