Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Recalled by Datascope Corporation Due to Certain lots containing undersized dilator.
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
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Quantity: 10,427 units
Why Was This Recalled?
Certain lots containing undersized dilator.
Where Was This Sold?
Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
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