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U.S. Department of Health and Human Services

Class 1 Device Recall HydroFinity Guidewire

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  Class 1 Device Recall HydroFinity Guidewire see related information
Date Initiated by Firm May 28, 2014
Date Posted June 25, 2014
Recall Status1 Terminated 3 on January 13, 2015
Recall Number Z-1814-2014
Recall Event ID 68419
510(K)Number K121398  
Product Classification Wire, guide, catheter - Product Code DQX
Product HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.

0.035 OD, Standard Shaft, Angled Tip, 260 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.
Code Information Model HPRA35260- all lots.
Recalling Firm/
Manufacturer		 Nitinol Devices and Components, Inc.
47533 Westinghouse Dr
Fremont CA 94539-7463
For Additional Information Contact Mark A. Turco
202-310-5120
Manufacturer Reason
for Recall		 Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
FDA Determined
Cause 2		 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 covidien8770@stericycle.com. ¿ 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 covidien8770@stericycle.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = GUIDEPATH MEDICAL, INC.
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