Aug

2017

CS 100i Intra-Aortic Balloon Pump Classi

Company:Maquet Datascope Corp – Cardiac Assist Division
Date of Enforcement Report 8/2/2017
Class lI:

PRODUCT

CS 100i Intra-Aortic Balloon Pump.
Recall Number Z-2736-2017

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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CS 100i Intra-Aortic Balloon Pump Classi

Amy Sellers

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