Recalling Firm / Manufacturer

Medtronic Perfusion Systems

Product

Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.

Code Information

Model Number: R5100052-Serial Numbers: 115, 118, 124, 138, 140, 141, 148, 113, 116, 117, 122,127, 130, 137 103, 109, 132, 135, 105, 107, 108, 110, 131, 133.

Reason of Recall

Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

Date Recall Initiated

June 04, 2007

Action

There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.