USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
FDA Recall Z-1362-2016 · Posted None
Recalling FirmUs Endovascular
Recall StatusTerminated
Product CodeLIT
Date Initiated2016-02-11
Date Terminated2017-11-30
Product Quantity843 catheters
Reason for Recall
Product may kink during use rendering the product unusable.
Firm 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 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.
Root Cause
Device Design
Distribution Pattern
US Distribution to the states of : AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.