Datascope Cardiosave Rescue IABP Recalled for Cybersecurity Vulnerabilities
Datascope Corp. is recalling Cardiosave Rescue IABP units due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a cybersecurity vulnerability leading to potential loss of communication, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Datascope Corp. is recalling the Cardiosave Rescue IABP, a medical device used to inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle. The recall affects model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. A total of 10,087 units were distributed worldwide and nationwide in the US.
The recall is being issued because there are 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 report any specific illnesses, injuries, or deaths associated with this recall.
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 Rescue 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 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiac Support
- Affected units
- 10,087
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 Systems. UDI: 10607567112312 10607567108407 10607567113449
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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