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

Recall Z-1384-2018 — Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreas

U.S. FDA — Device Enforcement · United States · 2018-02-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1384-2018
Date of alert
2018-02-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Datascope Corporation
Product category
device
Product type
Devices
Reported risk: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
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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