Nitinol Devices and Components, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1816-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Product Classification:

Class I

Date Initiated: May 28, 2014

Date Posted: July 2, 2014

Recall Number: Z-1816-2014

Event ID: 68419

Reason for Recall:

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Status: Terminated

Product Quantity: 8485 in US, 9595 - ROW - total, all models

Code Information:

Model HPRS35180- all lots.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated