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
FDA Recall Z-1507-2021 · Posted 2021-04-28
Recalling FirmDatascope Corp.
Recall StatusOpen, Classified
Product CodeDSP
Date Initiated2021-03-22
Product Quantity10087 total
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).
Firm Action
URGENT MEDICAL DEVICE CORRECTION notification letters dated 3/22/21 were distributed to customers.
PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL
CARDIOSAVE HYBRID and CARDIOSAVE RESCUE IABP USERS WITHIN YOUR
HOSPITAL / FACILITY.
IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS
TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION
FOR APPROPRIATE ACTION.
Corrective Action:
Datascope/Getinge is currently developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility.
Please complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the
completed form to Datascope/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-800-506-1644.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.