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.
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: 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.
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.
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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