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

Recall Z-0091-2022 — Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-0

U.S. FDA — Device Enforcement · United States · 2021-09-21 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0091-2022
Date of alert
2021-09-21
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: A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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