Recall Z-2756-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central
| Date | Sep 8, 2016 (initiated Aug 12, 2016) |
| Status | Terminated |
| Reason | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. |
| Root cause | Process control |
| Action | LivaNova issued an Urgent Safety Alert letter via certified mail on August 12, 2016 to all affected customers. The letter instructed customers to check their inventory to determine if the Cannulae belongs to the product code and lots listed. If the customer does not have any of the products described in the communication, please complete the response form below and return it per the instructions indicated on the form; otherwise, please check the tip angle to determine if it is conforming to specifications. If specification is not met, please file a complaint through your normal process whethe |
| Quantity | 200 units worldwide |
| Distribution | Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943934 | AORTIC ARCH CANNULAS Sorin Group Italia S.R.L., Jun 2, 1995 |