Z-0813-2016Class II

Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046...

Name: Z-0813-2016 Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046...
Creator: Sorin Group USA, Inc.
Published: 2016-01-25
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2016-01-25 / Terminated / root cause: manufacturing process

FDA source

Sorin Group USA, Inc. began a recall of Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a... on 2016-01-25. FDA classified it as Class II and gives the reason as "Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case". 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-0813-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-25
Posted: 2016-02-16
Terminated: 2016-10-24
Recalling firm: LivaNova USA, Inc.
Product: Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail [email protected]. We sincerely apologize for this inconvenience and thank you in advance for your support
Quantity in commerce: 60
Distribution: US Distribution to CA., and Internationally to Canada.
Product codes and lots: lot - 1529300018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0813-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0813-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-16

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)