Datascope Corp.: Medical Device Recall in 2024 - (Recall #: Z-0311-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 17, 2024

Date Posted: November 13, 2024

Recall Number: Z-0311-2025

Event ID: 95396

Reason for Recall:

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

Status: Ongoing

Product Quantity: 160 units

Code Information:

UDI-DI: 10607567107974; Lot Number: 3000344298

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated