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Recall Observatory FDA recall evidence

Device product

CS 100 Intra-Aortic Balloon Pump

Z-2737-2017

June 16, 2017

Class I

Product summary

Firm
Maquet Datascope Corp - Cardiac Assist Division
Event
Event 77566
Status
Terminated
Classification
Class I
Quantity
12,319 units total
Official record key
device-enforcement:Z-2737-2017

Official wording

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.

Code information: 0998-XX-3013-XX, 0998-UC-3013-XX

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.