The Recall Desk
HighFDA (Devices)·Z-1277-2023·Announced 2023-03-29

Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall

Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a high-risk cardiac support device with a theoretical performance-related hazard and no reported injuries, meeting the rubric criterion for 'High' severity where injury has not yet been reported.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. A total of 391 units have been affected.

The Safety Disk in these devices may not meet required performance specifications. This could impact the displacement volume of the intra-aortic balloon catheter.

The potential failure may result in slightly reduced balloon inflation during therapy or a reduction in the degree of augmentation provided to the patient during treatment. No injuries or illnesses have been reported in connection with this issue.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Device
Hazard
Affected units
391

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Model Number: 0998-00-0800-75
  • UDI-DI: 10607567112312
  • Model Number: 0998-00-0800-83
  • UDI-DI: 10607567108407
  • Model Number: 0998-00-0800-85
  • UDI-DI: 10607567113449
  • Serial Numbers: CA237026J3 CH231276C6

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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