Product Wiki · Recalls · U.S. FDA — Device Enforcement

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

U.S. FDA — Device Enforcement · United States · 2017-06-16 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2736-2017
Date of alert
2017-06-16
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Maquet Datascope Corp - Cardiac Assist Division
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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