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.
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 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…
- 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 →- 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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