Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae ar

FDA device recall Z-2756-2016 · posted 2016-09-08 · Terminated

Recall details

Recalling firm

Sorin Group USA, Inc.

Reason for recall

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.

Action taken

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 whether you decide to keep it and use it or return the product to Sorin Group; if you are not willing to use it, return the affected parts to Sorin Group USA. Please contact Customer Service 1-S00-650-2623 or email CustomerService@livanova.com to have a Return Material Authorization (RMA) issued. Complete the Customer Response Form attached to this letter to acknowledge receipt of this letter. Please return this form no later than September 15, 2016. For questions regarding this recall call 303-467-6306.

Root cause

Process control

Status

Terminated

Product code

DWF

Quantity affected

200 units worldwide

Distribution

Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.

Date initiated

2016-08-12

Date posted

2016-09-08

Date terminated

2017-03-27

Location

Arvada, CO

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