FDA Medical Device Recalls (openFDA)
Nitinol Devices and Components, Inc.: 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.
- Recall number
- Z-1814-2014
- Recalling firm
- Nitinol Devices and Components, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-05-28
- Posted
- 2014-06-25
- Terminated
- 2015-01-13
- Reason
- Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- 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 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
- 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.
- Lot, serial or model codes
- Model HPRA35260- all lots.
- 510(k) numbers
- ["K121398"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3007635982
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28