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

Recall Z-3135-2024 — CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

U.S. FDA — Device Enforcement · United States · 2024-08-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3135-2024
Date of alert
2024-08-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Datascope Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10607567112312
Reported risk: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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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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.