FDAFDA · Food and drugs·Recall number Z-1383-2018
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc 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 decreases the work of the left ventricle.
Published April 25, 2018 · Recall initiated: February 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corporation
- Distributor
- US Nationwide Distribution
- Lot
- 0684 00 0295 01U and 0684 00 0295 02U
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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