Z-2147-2016Class II

AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and...

Name: Z-2147-2016 AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and...
Creator: Sorin Group USA, Inc.
Published: 2016-06-22
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2016-06-22 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be... on 2016-06-22. FDA classified it as Class II and gives the reason as "Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of...". 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-2147-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-07-08
Terminated: 2017-03-27
Recalling firm: LivaNova USA, Inc.
Product: AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, LivaNova, sent an "Urgent Safety Alert" field communication letter dated June 22, 2016 via certified mail to consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: check your inventory to determine if you own Cannulae, if no inventory, complete the response form and return it per instructions indicated on form.; check the tip angle to determine if it is conforming to specifications, if specifications not met, file a complaint through your normal process whether you decide to keep it, use it or return it to Sorin Group; If you are not willing to use it, return affected product parts to Sorin Group USA,; contact Customer Service at 1-800-650-2623 or email CustomerService@livanova,com to have a RMA issued, and complete and return the Customer Response Form no later than July 20, 2016 via Fax at 303-467-6502 or by e-mail to [email protected]. If you need support for the execution of these actions, please contact your LivaNova sales representative or call Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT). For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT) or e-mail [email protected].
Quantity in commerce: 5740
Distribution: Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.
Product codes and lots: Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2147-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2147-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-08

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)