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, 0998-00-0800-52, 09
Check against the official notice below — it lists the full affected range.
The Datascope Corp. Cardiosave Hybrid IABP is a medical device used to inflate and deflate intra-aortic balloons, providing temporary support to the heart's left ventricle through counterpulsation. The device has been recalled due to cybersecurity vulnerabilities found in a widely used low-level TCP/IP software library. These vulnerabilities may cause a loss of communication between the device and the Hospital Information System/Clinical Information System (HIS/CIS). Approximately 10,087 units have been distributed worldwide, including throughout the United States.
According to the recall notice, the source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide distribution - US Nationwide distribution. Quantity: 10087 total Lot/code info: All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.