The Recall Desk
SevereFDA (Devices)·Z-2149-2023·Announced 2023-07-26

Cardiosave Hybrid IABP may fail to charge batteries, interrupting therapy

The Cardiosave Hybrid Intra-Aortic Balloon Pump may lose the ability to charge batteries in one or both bay slots, potentially interrupting critical therapy if disconnected from AC power. Low battery alarms may alert users before therapy is interrupted.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum classification of Severe (score 4). While the potential for therapy interruption on a critical life-support device represents significant risk, no deaths, serious injuries, or incidents have been reported in the source material.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) across multiple model numbers due to a battery charging defect.

The device may lose the ability to charge batteries in one or both battery bay slots. If batteries fail to charge and the device is disconnected from AC power, therapy may be interrupted. Low battery alarms may alert users to the problem.

Approximately 4,586 units have been distributed in the United States, with an additional 4,588 units distributed internationally to over 60 countries. The Cardiosave Hybrid IABP is used in critical care to provide temporary mechanical circulatory support.

Healthcare facilities should contact Datascope Corp. or the FDA for further guidance regarding affected devices.

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
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard

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.

See all 2 products in this recall →

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Same manufacturer · Datascope Corp.

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Same hazard · battery charging failure

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