The Recall Desk
HighFDA (Devices)·Z-0075-2022·Announced 2021-10-13

Cardiosave Hybrid IABP Display Helium Indicator May Misread in Electromagnetic Interference

Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.

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: This is an FDA Class II recall without reported illnesses or injuries. However, the defect poses a risk of harm: inaccurate helium pressure readings in a critical care device could affect clinical decision-making and patient treatment. Per the severity rubric, a risk-of-harm product without reported injury scores as High.

Plain-English summary

Datascope Corp. is recalling specific models of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) due to a defect in the helium indicator display. The indicator may overrepresent the amount of helium in the device when electromagnetic interference is present. The recall affects approximately 5,054 units distributed in the United States and 5,033 units distributed internationally across ten model numbers.

The helium indicator malfunction could result in inaccurate readings that affect clinical decision-making regarding the balloon pump's operation. Electromagnetic interference from nearby medical or electrical equipment can trigger the display error.

Healthcare facilities and providers should be aware of this potential display malfunction, particularly in high-electromagnetic-interference environments. Additional information and guidance should be obtained from the manufacturer, Datascope Corp.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiovascular / Intra-Aortic Balloon Pump
Hazard
  • measurement-error
  • display-malfunction

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

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