Agency classClass IOur severity:Severe FDA (Devices)·Z-1812-2014·Announced 2014-07-02

FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage

Nitinol Devices and Components 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 classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

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 involves Model HPRA35150, all lots, with a total of 8,485 units distributed in the US and 9,595 units distributed internationally.

The recall was initiated due to reports of the outer polymer jacket to the core wire being damaged during use. The product was manufactured for Covidien in Plymouth, MN, and manufactured by NDC Inc. in Fremont, CA, with production in Costa Rica. Distribution was worldwide, including the United States and countries such as Italy, France, Norway, Sweden, Germany, Belgium, the United Kingdom, and Canada.

Healthcare providers and facilities should stop using the affected guidewires and contact the recalling firm for further instructions. Consumers are not expected to have these devices in their homes, as they are professional medical devices used in clinical settings.

The recalled product

Product: HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled 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

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 HPRA35150 - 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
Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage
FDA (Devices) · 2014-07-02

Same hazard · structural defect