Maquet Datascope Corp - Cardiac Assist Division recalls CS 300 Intra-Aortic Balloon Pump

Recall date

June 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2738-2017

FDA classification

Class I

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

Worldwide Distribution - (in over 100 countries) US (Nationwide)

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CS 300 Intra-Aortic Balloon Pump