Datascope Corp.: Medical Device Recall in 2021 - (Recall #: Z-0336-2022)

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 IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.

Product Classification:

Class I

Date Initiated: November 15, 2021

Date Posted: December 22, 2021

Recall Number: Z-0336-2022

Event ID: 88983

Reason for Recall:

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

Status: Ongoing

Product Quantity: 5,566 (US); 6,354 (OUS)

Code Information:

All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-65, 10607567113432

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated