Z-2737-2017 Class I Terminated
FDA device recall Z-2737-2017 was initiated by Maquet Datascope Corp - Cardiac Assist Division on June 16, 2017 and is designated Class I. 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 fai… The recall status is terminated (terminated November 29, 2019). Affected quantity: 12,319 units total.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- June 16, 2017
- Termination Date
- November 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,319 units total
Product Description
CS 100 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 Pattern
Worldwide Distribution - (in over 100 countries) US (Nationwide)
Code Information
0998-XX-3013-XX, 0998-UC-3013-XX