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Maquet Datascope Corp - Cardiac Assist Division recalls CS 300 Intra-Aortic Balloon Pump
Recalled August 2, 2017 · FDA recall Z-2738-2017 · Maquet Datascope Corp - Cardiac Assist Division
Hazard
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. · FDA Class I
Units
12,319 units total
Sold at
Worldwide Distribution - (in over 100 countries) US (Nationwide)
Description
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.
Product
CS 300 Intra-Aortic Balloon Pump
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →