Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage
Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire."
Plain-English summary
Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic guidewire, a sterile medical device used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures. The recall is being conducted due to reports that the outer polymer jacket of the guidewire may be damaged during use.
The affected product is the HydroFinity Hydrophilic guidewire, Model HPSA35180, which features a 0.035 OD, stiff shaft, and angled tip with a length of 180 cm. The device was manufactured by NDC Inc. in Costa Rica for Covidien. The recall covers all lots of this specific model.
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. Users of this medical device should stop using the affected guidewires and contact the recalling firm for further instructions.
The recalled product
- Product
- HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity…
- 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 HPSA35180- 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 →- SevereFDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
- SevereNitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
- SevereNitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
FDA (Devices) · 2014-07-02
- SevereNitinol 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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- Severe
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