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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
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.
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