USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Recall
- Recall Number
- Z-1362-2016
- Event Number
- 73171
- Firm
- Us Endovascular
- FEI Number
- 3010747597
- Product Code
- LIT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 11, 2016
- Terminated
- November 30, 2017
- Address
- 1150 Milwaukee St, Saint Louis, MO, 63122-7336
Description
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Product may kink during use rendering the product unusable.
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 should be determined via fluoroscopy. 3. For contralateral procedure, the USE014OTW has to be preferred to Ebony 014 Rx. NATEC Medical Ltd and our distributor US Endovascular are committed to keeping you and your healthcare professional informed of issues and solutions concerning our products and services. Should you have any questions regarding this or any other matter regarding your USE 014Rx PTA catheter, please do not hesitate to contact our distributor: US Endovascular at (314) 341-4930.
US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
843 catheters