Datascope Corp.: Device Recall

Recall #Z-3136-2024 · 08/08/2024

Class I: Dangerous

Recall Details

Recall Number: Z-3136-2024
Classification: Class I
Product Type: Device
Recalling Firm: Datascope Corp.
Status: Ongoing
Date Initiated: 08/08/2024
Location: Mahwah, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,475 units

Reason for Recall

Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

Product Description

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

Distribution Pattern

International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.

Other Recalls by Datascope Corp.

Class II: Risk 11/04/2025

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II: Risk 11/04/2025

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class III: Low Risk 10/23/2025

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class III: Low Risk 10/23/2025

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class II: Risk 09/17/2024

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

View all recalls by Datascope Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.