The Recall Desk
HighFDA (Devices)·Z-0076-2022·Announced 2021-10-13

Cardiosave IABP helium indicator may show inaccurate readings during electromagnetic interference

Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit 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 FDA Class II recall involves potential measurement errors in a life-support device, but no injuries or illnesses have been reported. The hazard is theoretical and dependent on the presence of electromagnetic interference.

Plain-English summary

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) models 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 worldwide. All lots are affected.

The Helium Indicator on the Cardiosave display may overrepresent the amount of helium in the unit in the presence of electromagnetic interference. This can result in inaccurate readings of the device's helium level.

The affected devices have been distributed in the United States and internationally. Healthcare providers should be aware of the potential for inaccurate helium readings when electromagnetic interference is present and should take appropriate precautions when using or monitoring these devices.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device
Hazard
  • measurement-error
  • electromagnetic-interference

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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