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
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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic Guidewire, Model HPRS35260, all lots. The recall is due to reports that the outer polymer jacket to the core wire was damaged during use. The product is a sterile Nitinol guidewire with a hydrophilic coating, 0.035 OD, Standard Shaft, Straight Tip, and 260 CM Length, manufactured for Covidien in Plymouth, MN, and manufactured by NDC Inc. in Fremont, CA, in Costa Rica.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada. The total quantity involved is 8,485 units in the US and 9,595 units in the rest of the world.
Healthcare providers and facilities should stop using the affected guidewires and contact the recalling firm for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 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.
- 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 HPRS35260- 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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