Datascope recalls Cardiosave Rescue IABP devices due to cybersecurity vulnerabilities that could disrupt hospital information systems. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. No remedy is specified in the recall notice.
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Datascope is recalling Cardiosave Rescue IABP devices that use intra-aortic balloons for heart support. The recall is due to cybersecurity vulnerabilities in the software that could disrupt hospital information systems. This affects hospital equipment, not end-users directly.
The devices use a low-level TCP/IP software library with cybersecurity vulnerabilities. If exploited, this could cause loss of communication with hospital information systems, potentially disrupting patient care and medical records.
Hospitals and healthcare facilities using the Cardiosave Rescue IABP devices are affected. Medical staff and patients using these devices may be at risk if the hospital information systems are disrupted.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. The recall applies to all systems that use these models.
Identify the model number on the device to confirm if it is one of the recalled models.
The recall does not specify a remedy, so there is no instruction to stop using the device.
The recall notice does not provide specific actions for hospitals to take.
The recall addresses cybersecurity risks to hospital information systems, not direct patient safety risks.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1507-2021 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1507-2021 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
