Z-2756-2016Class II

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

Name: Z-2756-2016 Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch...
Creator: Sorin Group USA, Inc.
Published: 2016-08-12
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2016-08-12 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of 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... on 2016-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2756-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-09-08
Terminated: 2017-03-27
Recalling firm: LivaNova USA, Inc.
Product: 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 circulatory system but they are not intended to control, diagnose, monitor or correct a defect. 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
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected] 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.
Quantity in commerce: 200 units worldwide
Distribution: Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
Product codes and lots: Lot Numbers: 1526500032, 1529300026, 1602600042.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2756-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2756-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08
Z-2757-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-08

Product code DWF

K943934Class IIAortic Arch CannulasSorin Group Italia S.R.L. / cleared 1995-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)