Nitinol Devices and Components, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1822-2014)

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; 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 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-1822-2014

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 HPSS35180- 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