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

Recall Z-2433-2023 — Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-

U.S. FDA — Device Enforcement · United States · 2023-07-31 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2433-2023
Date of alert
2023-07-31
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Datascope Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10607567109053
Reported risk: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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