Medtronic Performer CPB-Universal R2100375 recallZ-1090-2007 · Medtronic Perfusion Systems · initiated Jun 4, 2007
Terminated All recalls posted in July 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1090-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 4, 2007
- Posted by the FDA
- Jul 23, 2007
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 24 units
- Product code
- DTQ
- FDA submissions
- K052555, K070213
- 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 description
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 (models, lots, serial 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.
Other devices under the same FDA submission
2 devices cleared under K052555, K070213 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Performer™ R5100052Medtronic, Inc. · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS10 reports
- Performer™ RR5100052Medtronic, Inc. · CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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