Medtronic Perfusion Systems 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
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.
Products Sold
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.
Medtronic Perfusion Systems is recalling Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System i due to Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB)). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, MI, MN, NY, ND, OH, PA
Page updated: Jan 10, 2026