Datascope recalls Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities that could disconnect hospital information systems. Affected models include specific serial numbers and system versions. No remedy is listed in the official 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 Hybrid IABP devices that use intra-aortic balloons for heart support. The recall is due to cybersecurity vulnerabilities that could cause communication loss with hospital information systems, potentially disrupting critical medical data flow.
The devices use a low-level TCP/IP software library with cybersecurity vulnerabilities that could lead to loss of communication with hospital information systems. This might disrupt critical medical data flow and patient monitoring if the system is not properly secured.
Healthcare facilities using the Cardiosave Hybrid IABP devices with the listed model numbers and UDI codes are most at risk. Patients receiving this device for temporary heart support may be affected if the hospital system is compromised.
Check for model numbers 0998-00-0800-32 through 0998-00-0800-65 and UDI codes listed in the recall notice. The devices are used in hospitals for temporary heart support via intra-aortic balloon pumps.
Identify the model number on the device label to see if it matches the listed numbers: 0998-00-0800-32 through 0998-00-0800-65.
The recall is due to cybersecurity vulnerabilities in the low-level TCP/IP software library that could result in loss of communication with hospital information systems.
The official recall notice does not specify a remedy or action steps for affected devices.
Yes, the affected model numbers are 0998-00-0800-32 through 0998-00-0800-65.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1506-2021 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1506-2021 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.
