Company:Maquet Datascope Corp – Cardiac Assist Division
Date of Enforcement Report 8/2/2017
ClasslI:
PRODUCT
CS 300 Intra-Aortic Balloon Pump
Recall Number Z-2738-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Maquet Datascope Corp – Cardiac Assist Division Mahwah, NJ on 6/16/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
12,319 units total
DISTRIBUTION
Nationwide and Internationally
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