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Recall Observatory FDA recall evidence

Device 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 interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Z-1822-2014

May 28, 2014

Class I

Product summary

Firm
Nitinol Devices and Components, Inc.
Event
Event 68419
Status
Terminated
Classification
Class I
Quantity
8485 in US, 9595 - ROW - total, all models
Official record key
device-enforcement:Z-1822-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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