FDA Medical Device Recalls (openFDA)
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 number
- Z-1090-2007
- 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.
- Status
- Terminated
- Initiated
- 2007-06-04
- Posted
- 2007-07-23
- Terminated
- 2008-03-02
- Reason
- Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K052555","K070213"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28