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

Recall Z-2431-2023 — 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-2431-2023
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 were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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.