Class II

Medical Device Recall: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Datascope Corp. · September 17, 2024

Reason for Recall

There is discrepant labeling on the inner and outer packaging of the device.

Distribution

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

Quantity Affected

160 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0311-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Datascope Corp. Medical Device Recall: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 | SafeCheck