Recall Z-2736-2017— Maquet Datascope Corp - Cardiac Assist Division

Name: FDA recall Z-2736-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-16

Class I · Terminated

Class I FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2017-06-16, terminated 2019-11-29. It names one FDA 510(k) clearance: K031636. Product: CS 100i Intra-Aortic Balloon Pump. 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: Maquet Datascope Corp - Cardiac Assist Division
Classification: Class I
Status: Terminated
Initiated: 2017-06-16
Terminated: 2019-11-29
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XXDatascope Corp.·cleared 2003-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CS 100i 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.