Recall Z-1362-2016 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Us Endovascular
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
| Date | Feb 11, 2016 |
| Status | Terminated |
| Reason | Product may kink during use rendering the product unusable. |
| Root cause | Device Design |
| Action | NATEC Medical ltd.sent an Urgent Medical Device Advisory Notice dated March 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Warnings: This device should be used only by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of angioplasty. What action do you need to take: 1. Always use a guiding catheter when contralateral access is needed. 2. Always insert cautiously the PTA catheter inside the guiding catheter, and if any resistance is felt, the cause s |
| Quantity | 843 catheters |
| Distribution | US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152230 | Ebony PTA .014 RX Pheripheral Dilatation Catheter Natec Medical, Sep 3, 2015 |