Recall Z-1815-2014 ยท DQX Wire, Guide, Catheter
Nitinol Devices and Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 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
| Date | Jun 25, 2014 (initiated May 28, 2014) |
| Status | Terminated |
| 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 C |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121398 | CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) Guidepath Medical, Inc., Dec 13, 2012 |