Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CS 300 Intra-Aortic Balloon Pump Recalled by Maquet Datascope Corp - Cardiac Assist Division Due to The device failed to pump due to an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Datascope Corp - Cardiac Assist Division directly.
Affected Products
CS 300 Intra-Aortic Balloon Pump
Quantity: 12,319 units total
Why Was This Recalled?
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Datascope Corp - Cardiac Assist Division
Maquet Datascope Corp - Cardiac Assist Division has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report