Agency classClass IOur severity:Severe FDA (Devices)·Z-1822-2014·Announced 2014-07-02

Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to 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, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences.

Plain-English summary

Nitinol Devices and Components, Inc. is recalling the HydroFinity Hydrophilic Guidewire, model HPSS35180, all lots. The product is a 0.035-inch outer diameter, stiff shaft, straight tip, 180 cm length guidewire manufactured for Covidien in Plymouth, MN, and by NDC Inc. in Fremont, CA. The device is used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures.

The recall was initiated due to reports that the outer polymer jacket of the guidewire was damaged during use. The agency has classified this recall as Class I, which indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recall affects 8,485 units in the United States and 9,595 units internationally, with distribution to 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 on return or replacement.

The recalled product

Product: HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and…
Manufacturer: Nitinol Devices and Components, Inc.
Category: Medical Device — Interventional Guidewire
Hazard: structural-defect

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 HPSS35180- 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