Recall Z-1507-2021

Datascope Corp. · initiated March 22, 2021

Class III Open, Classified

Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws

Product

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

Codes / lots: All Systems. UDI: 10607567112312 10607567108407 10607567113449

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).

FDA-determined cause: Software design

Action taken

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 cardiosaveripple20.act@getinge.com or by faxing the form to 1-800-506-1644.

Details

Recall number
Z-1507-2021
Initiated
March 22, 2021
Posted by FDA
April 28, 2021
Product code
DSP – System, Balloon, Intra-Aortic And Control
Quantity
10087 total
Distribution
Worldwide distribution - US Nationwide distribution.
Recalling firm
Datascope Corp., Mahwah, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1506-2021 Class IIICardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic…There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result… 03/22/2021Open, Classified