Z-0770-2012

Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA...

Name: Z-0770-2012 Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA...
Creator: Sorin Group USA, Inc.
Published: 2011-12-02
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2011-12-02 / Terminated / root cause: design

FDA source

Sorin Group USA, Inc. began a recall of Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004... on 2011-12-02. The reason FDA records is "Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0770-2012
Status: Terminated
Initiated: 2011-12-02
Posted: 2012-01-14
Terminated: 2012-06-13
Recalling firm: LivaNova USA, Inc.
Product: Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.
Quantity in commerce: 41,201 units (11,182 as standalone devices/ 30,019 included in heart and lung packs)
Distribution: Worldwide Distribution
Product codes and lots: All Lots.

Product code DTZ

K073380Class IISynthesis Ph.i.s.i.o. Adult Membrane Oxygenator with Integrated Areterial Filter and Hardshell Venous/cariotomy ReservoiSorin Group Italia S.R.L. / cleared 2008-02-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)