Recall Z-1506-2021— Datascope Corp.

Name: FDA recall Z-1506-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-22

Class III · Ongoing

Class III FDA medical device recall by Datascope Corp., initiated 2021-03-22. It names 3 FDA 510(k) clearances: K163542, K151254, K112372. Product: 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. 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)..

Recalling firm: Datascope Corp.
Classification: Class III
Status: Ongoing
Initiated: 2021-03-22
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp.·cleared 2017-01-31
K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.·cleared 2015-07-02
K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC·cleared 2011-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.