The Recall Desk
HighFDA (Devices)·Z-1229-2023·Announced 2023-03-15

Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

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 device with a documented mechanism of failure that could impact critical cardiac support function, but no deaths or injuries have been reported. This meets the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Datascope Corp. is recalling 8,909 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) due to failures of the high pressure helium regulator. The affected models include variants with model numbers 0998-00-0800-31 through 0998-UC-0800-53, distributed nationwide and internationally.

The defect occurs when the helium regulator fails, potentially causing a helium leak from the Hospital Cart. When this failure happens, the Pump Console's internal helium reservoir will not be properly replenished when the pump is docked into an affected Hospital Cart. This may result in an insufficient amount of helium available for the device to function properly.

The recalled units were distributed to hospitals and medical facilities nationwide and globally. Healthcare providers using Cardiosave Hybrid IABP equipment should contact Datascope Corp. to determine whether their devices are affected by this recall and to obtain guidance on replacement, repair, or corrective action.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 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, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support / Intra-Aortic Balloon Pump
Hazard
  • helium-leak
  • device-malfunction
  • insufficient-gas-supply

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)

  • All Serial Numbers. Model Number: 0998-00-0800-31
  • UDI-DI:10607567109053
  • Model Number: 0998-00-0800-32
  • UDI-DI: 10607567111117
  • Model Number: 0998-00-0800-33
  • UDI-DI: 10607567109008
  • Model Number: 0998-00-0800-34
  • UDI-DI: 10607567111940
  • Model Number: 0998-00-0800-35
  • UDI-DI: 10607567109107
  • Model Number: 0998-00-0800-45
  • UDI-DI: 10607567108421
  • Model Number: 0998-00-0800-52
  • UDI-DI: 10607567108438
  • Model Number: 0998-00-0800-53
  • UDI-DI: 10607567108391
  • Model Number: 0998-00-0800-55
  • UDI-DI: 10607567108414
  • Model Number: 0998-00-0800-65
  • UDI-DI: 10607567113432

Distribution

Distributed nationwide across the United States.

Related recalls

Same category