The Recall Desk
HighFDA (Devices)·Z-1506-2021·Announced 2021-05-05

Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but the potential loss of communication to critical hospital systems presents a significant safety risk.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Hybrid IABP, a medical device used to inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle. The recall affects specific model numbers, including 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, and 0998-00-0800-65.

The recall is due to cybersecurity vulnerabilities in a widely used low-level TCP/IP software library. These vulnerabilities may result in a loss of communication to the Hospital Information System or Clinical Information System (HIS/CIS). The source text does not specify the number of affected units, specific dates, or the exact geographic distribution beyond the product's general usage context.

Healthcare facilities and users of these devices should contact Datascope Corp. for further instructions on how to address the cybersecurity vulnerabilities and ensure continued safe operation of the devices.

The recalled product

Product
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45,
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiovascular
Hazard
Affected units
10,087

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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