Z-1090-2007

Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an...

Name: Z-1090-2007 Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an...
Creator: Medtronic Perfusion Systems
Published: 2007-06-04
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2007-06-04 / Terminated

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used... on 2007-06-04. The reason FDA records is "Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1090-2007
Status: Terminated
Initiated: 2007-06-04
Posted: 2007-07-23
Terminated: 2008-03-02
Recalling firm: 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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
FDA root cause: Other
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.
Quantity in commerce: 24 units
Distribution: Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.
Product codes and lots: 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.

Product code DTQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)