Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories Recalled by Datascope Corp. Due to There is discrepant labeling on the inner and...
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 Corp. directly.
Affected Products
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Quantity: 160 units
Why Was This Recalled?
There is discrepant labeling on the inner and outer packaging of the device.
Where Was This Sold?
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
About Datascope Corp.
Datascope Corp. has 66 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report