Z-2871-2017Class II

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile

Name: Z-2871-2017 Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile
Creator: Sorin Group USA, Inc.
Published: 2017-06-09
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-06-09 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the... on 2017-06-09. FDA classified it as Class II and gives the reason as "Identification of excess plastic on the tip of the cannula". 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-2871-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-09
Posted: 2017-08-10
Terminated: 2023-11-09
Recalling firm: LivaNova USA, Inc.
Product: Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Identification of excess plastic on the tip of the cannula.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LivaNova sent an Urgent Medical Device letter dated June 16, 2017 to affected customers via certified mail or e-mail. The letter identified the affected product, problem and actions to be taken. The notice instructs customers to remove all recalled product from inventory and contact LivaNova Customer Support at 800-650-2623 to arrange for product return and replacement.
Quantity in commerce: 105,770 units
Distribution: Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.
Product codes and lots: Model No. NA-1116, NA-1118, NA-1126, NA-1136, NA-1206, NA-1207, NA-1208, NA-1316, NA-1327, NA-1337, NA-1338, RA-1117, RA-1126, RA-1127, RA-1128A, RA-1136, RA-1137A, RA-1137, RA-1138, RA-1206; Lot No. 1407000078 to 1705200165, S140979 to S141841.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2871-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2871-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-16	2017-08-10

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)