FDA recall Z-2738-2017

Maquet Datascope Corp - Cardiac Assist Division · Class I · device

Product

CS 300 Intra-Aortic Balloon Pump

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2017-06-16
Report date: 2017-08-02
Termination date: 2019-11-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2017