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

Recall Z-2149-2023 — Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-U

U.S. FDA — Device Enforcement · United States · 2023-06-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2149-2023
Date of alert
2023-06-05
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: IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.