Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic Recalled by Datascope Corporation Due to The U.S. Instructions For Use for the Mega...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corporation directly.
Affected Products
Intra-Aortic Balloon Catheter Mega 8FR 50cc 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.
Quantity: 12744
Why Was This Recalled?
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Datascope Corporation
Datascope Corporation has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report