The Recall Desk
HighFDA (Devices)·Z-1232-2023·Announced 2023-03-15

Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

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 medical device recall for a cardiac pump where O-ring failures cause helium leaks and therapy interruption. No reported hospitalizations or injuries. Risk-of-harm product without reported injury meets Score 3 (High) per rubric.

Plain-English summary

The Cardiosave Rescue cardiac pump (Model 0998-00-0800-83), manufactured by Datascope Corp., is being recalled. A total of 47 units have been distributed, with 44 units in the US and 3 units internationally.

The quick disconnect fitting on the pump console contains O-rings that may become damaged, worn, or torn. When these O-rings fail, helium tank leaks develop. A depleted helium supply will interrupt therapy delivery.

Healthcare providers and patients using or scheduled to use the Cardiosave Rescue should verify whether their device is affected by contacting Datascope Corp. Patients should not attempt repairs themselves and should consult with their healthcare provider regarding any concerns about device functionality.

The recalled product

Product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
  • device-defect
  • therapy-interruption
  • helium-leak

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)

  • Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.

Distribution

Distributed nationwide across the United States.

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