The Recall Desk
HighFDA (Devices)·Z-3136-2024·Announced 2024-10-02

Cardiac Support Device Software Defect Risks Hemodynamic Instability

Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.

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: Although this is an FDA Class I recall, no illnesses, injuries, or deaths have been reported. The hazard is described as a theoretical risk of hemodynamic instability and data transmission failure, fitting the FDA rubric category of risk-of-harm products without reported injury, which defines the High category.

Plain-English summary

The CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP), manufactured by Datascope Corp., is an electromechanical cardiac support device used to inflate and deflate intra-aortic balloons. A software defect poses a risk of hemodynamic instability and failure of transmission of clinical data.

Approximately 5,475 units have been distributed internationally to 49 countries and territories including the United Arab Emirates, Argentina, Australia, Brazil, Canada, China, Germany, France, India, Japan, South Korea, Mexico, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and the United Kingdom. All lots of the affected product numbers are included in this recall.

Datascope Corp. has developed a software correction (Revision D.01) for affected devices outside the United States. Healthcare facilities and clinicians should implement this update to mitigate the risks of hemodynamic instability and clinical data transmission failure.

The recalled product

Product
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Device
Hazard
Affected units
5,475

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 (20)

  • Product No. 0998-00-0800-31
  • 0998-UC-0800-31
  • 0998-00-0800-32
  • 0998-00-0800-33
  • 0998-UC-0800-33
  • 0998-00-0800-34
  • 0998-00-0800-35
  • 0998-00-0800-36
  • 0998-00-0800-45
  • 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
  • UDI: 10607567109053
  • 10607567111117
  • 10607567109008
  • 10607567111940

Distribution

Distribution scope not specified by the agency.

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 · hemodynamic instability

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