The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1816-2014·Announced 2014-07-02

Nitinol HydroFinity Hydrophilic Guidewire Recalled for 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 medical device used to facilitate the introduction and placement of catheters and interventional devices during diagnostic or interventional procedures. The recall involves Model HPRS35180, which features a 0.035 OD, standard shaft, straight tip, and 180 cm length. The product was manufactured for Covidien in Plymouth, MN, and manufactured by NDC Inc. in Fremont, CA, with production in Costa Rica.

The recall is being conducted due to reports that the outer polymer jacket of the guidewire may be damaged during use. This defect could potentially compromise the integrity of the device during medical procedures.

The recall covers 8,485 units in the US and 9,595 units internationally, totaling 18,080 units across all models. Distribution was worldwide, including the United States (nationwide) and internationally to 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.

The recalled product

Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc.…
Manufacturer
Nitinol Devices and Components, Inc.
Category
Medical Device — Interventional Guidewire
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 HPRS35180- 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 →

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