Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An… recallZ-1924-2011 · Quest Medical, Inc · initiated Jul 29, 2010
Terminated All recalls posted in April 2011
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 Quest Medical, Inc 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
User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
FDA root cause category: Other
What the company is doing
Quest Medical Incorporated sent a "User Update" letter in July 2010 to consignees providing information concerning use of external heater-cooler untis with their device - Myocardial Protection System ( MPS) consoles. If you are installing an external heater-water cooler unit or have questions about this user update, please contact the Field Service department at Quest Medical, Inc. The number is 800.627.0026 or 1 972.390.9800.
Recall details
- Recall number
- Z-1924-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 29, 2010
- Posted by the FDA
- Apr 8, 2011
- Recalling firm
- Quest Medical, Inc
- Quantity
- 771 consoles
- Product code
- DTR
- FDA submissions
- K041979, K953838
- Distribution
- Nationwide, Canada, Saudi Arabia, Kuwait, Japan, and Italy
Product description
Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat exchanger, an arrest agent pump and an additive pump. The MPS console is used with the MPS sterile disposables with a built in heat exchanger. The device is used with on-pump or off-pump cardiac surgery.
Code information (models, lots, serial numbers)
MPS Serial Numbers: 2022, 2023, 2024, 2297, 2307, 2177, 2258, 2259, 2261, 2263, 2266, 2421, 2422, 1198, 1379, 1385, 1395, 2022, 2023, 2024, 2335, 2336, 2396, 9069, 1407, 1408, 1409, and 2078
Other devices under the same FDA submission
6 devices cleared under K041979, K953838 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MPS2 Console 5201260Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass1 death67 reports
- MPS 5001102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass42 reports
- MPS 5001102-ASQuest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass7 reports
- MPS Console 5001000Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass4 reports
- MPS2 console 5202260Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass2 reports
- Delivery Set 16C w/ AA 35cm Line 5161102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass1 report
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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