The Recall Desk
CriticalFDA (Devices)·Z-0886-2023·Announced 2023-01-25

Cardiosave IABP may shut down unexpectedly due to blood contamination

The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, the highest regulatory classification for medical devices. FDA Class I designates devices with a reasonable probability of causing serious adverse health consequences or death.

Plain-English summary

The Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), manufactured by Datascope Corp., including Models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, and 0998-UC-0800-85, is the subject of this FDA Class I recall.

The device may shut down unexpectedly when therapy is provided with a compromised intra-aortic balloon catheter, as blood may enter the pump during operation.

Approximately 46 units have been distributed worldwide, including throughout the United States and internationally to numerous countries.

Healthcare facilities currently using or possessing this device should contact Datascope Corp. immediately for guidance on appropriate next steps and device management.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard
Affected units
46

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 (10)

  • UDI-DI: 0998-00-0800-75
  • 10607567112312
  • 0998-00-0800-83
  • 10607567108407
  • 0998-00-0800-85
  • 10607567113449
  • 0998-UC-0800-75
  • 0998-UC-0800-83
  • 0998-UC-0800-85
  • 10607567113449.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

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Same hazard · device shutdown

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