Z-1819-2014Class I

HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft...

Name: Z-1819-2014 HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft...
Creator: Nitinol Devices and Components, Inc.
Published: 2014-05-28
License: https://open.fda.gov/license/

Confluent Medical Technologies, Inc / initiated 2014-05-28 / Terminated / root cause: design

FDA source

Nitinol Devices and Components, Inc. began a recall of HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for... on 2014-05-28. FDA classified it as Class I and gives the reason as "Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1819-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-06-25
Terminated: 2015-01-13
Recalling firm: Confluent Medical Technologies, Inc
Product: HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled 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 code: DQX Wire, Guide, Catheter
Reason for recall: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Root cause tag: design
FDA root cause: Device Design
Action: Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to:: 1) Stop using product listed in this letter immediately 2) Segregate this product from other inventory 3) Fill out the reply (verification) form at the end of this letter If you do not have any product identified in this letter, please fax or email the completed form to Covidien at (877) 523-9109 or [email protected]. If you do have product, your sales representative will assist you in completing the verification form and arranging for return of the product. Please fax the completed form to Covidien (877) 523-9109 or email to [email protected]. 4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits. This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. Customers with questions were instructed to call (202) 310-5120. For questions regarding this recall call 202-310-5120. _
Quantity in commerce: 8485 in US, 9595 - ROW - total, all models
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Product codes and lots: Model HPSA35180- all lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1812-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1813-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1814-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1815-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1816-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1817-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1818-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1819-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1820-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1821-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1822-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1823-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code DQX

K121398Class IICharlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. / cleared 2012-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)