Recall Z-1506-2021 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
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, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
| Date | Apr 28, 2021 (initiated Mar 22, 2021) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Software design |
| 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 |
| Quantity | 10087 total |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp., Jul 2, 2015 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp., Jan 31, 2017 |