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

Recall Z-0099-2019 — Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

U.S. FDA — Device Enforcement · United States · 2018-09-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0099-2019
Date of alert
2018-09-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Maquet Datascope Corp - Cardiac Assist Division
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10607567108391
Reported risk: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
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.