HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip
FDA device recall Z-1819-2014 · posted 2014-06-25 · Terminated
Recall details
- Recalling firm
- Nitinol Devices and Components, Inc.
- Reason for recall
- Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
- Action taken
- 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. _
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 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.
- Date initiated
- 2014-05-28
- Date posted
- 2014-06-25
- Date terminated
- 2015-01-13
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) (K121398) | Guidepath Medical, Inc. | 2012-12-13 |