Home / Recalls / Medical Devices
Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Recalled November 13, 2024 · FDA recall Z-0311-2025 · Datascope
Hazard
There is discrepant labeling on the inner and outer packaging of the device. · FDA Class II
Units
160 units
Sold at
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Description
There is discrepant labeling on the inner and outer packaging of the device.
Product
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Manufacturer(s)
Datascope Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →