Datascope Corp.: Medical Device Recall in 2021 - (Recall #: Z-0075-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

Product Classification:

Class II

Date Initiated: September 8, 2021

Date Posted: October 13, 2021

Recall Number: Z-0075-2022

Event ID: 88651

Reason for Recall:

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Status: Ongoing

Product Quantity: 5054 total (US), 5033 total (OUS)

Code Information:

All lots

Distribution Pattern:

Worldwide distribution - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated