Agency classClass IOur severity:Severe FDA (Devices)·Z-1821-2014·Announced 2014-07-02

Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because 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 recall is due to reports that the outer polymer jacket to the core wire was damaged during use.

The affected product is the HydroFinity Hydrophilic guidewire, Model HPSS35150, all lots. The device is manufactured by NDC Inc. in Costa Rica for Covidien. It is used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures.

The recall covers 8,485 units in the US and 9,595 units internationally. Distribution was worldwide, including the US, Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada. Users should stop using the affected guidewires and contact the recalling firm for instructions.

The recalled product

Product: HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 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.
Category: Medical Device — Interventional Guidewire
Hazard: structural-defect
device-failure

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 HPSS35150- 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 →

Same manufacturer · Nitinol Devices and Components, Inc.

See all →

Severe
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
Severe
Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage
FDA (Devices) · 2014-07-02
Severe
Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
FDA (Devices) · 2014-07-02
Severe
Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage
FDA (Devices) · 2014-07-02
Severe
FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage
FDA (Devices) · 2014-07-02

Same hazard · structural defect