Z-0192-2010

Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000Rx ONLYSORIN GROUP ITALIA via...

Name: Z-0192-2010 Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via...
Creator: Sorin Group USA, Inc.
Published: 2009-09-25
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2009-09-25 / Terminated / root cause: packaging

FDA source

Sorin Group USA, Inc. began a recall of Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy)... on 2009-09-25. The reason FDA records is "A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0192-2010
Status: Terminated
Initiated: 2009-09-25
Posted: 2009-11-13
Terminated: 2009-12-14
Recalling firm: LivaNova USA, Inc.
Product: Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th way Arvada (CO) 80004-3599" Intended for use in cardiopulmonary bypass procedures.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Customers were notified by an Urgent: Field Safety Notice, dated 9/25/09, and instructed to: check their inventory for the affected product, complete the customer response form and return or visually inspect all affected product before use. For additional information contact Sorin Group Customer Service at 1-800-650-2623.
Quantity in commerce: 808 units
Distribution: Worldwide Distribution -- US, Canada, Japan, and Europe.
Product codes and lots: Lot numbers: 0905220163, 0905220166, 0906240182, and 0906240185.

Product code KFM

K011835Class IICobe RevolutionCobe Cardiovascular, Inc. / cleared 2002-02-12

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)