Z-1506-2021Class III

Cardiosave Hybrid IABP -

Name: Z-1506-2021 Cardiosave Hybrid IABP -
Creator: Datascope Corp.
Published: 2021-03-22
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2021-03-22 / Open, Classified / root cause: software

FDA source

Datascope Corp. began a recall of Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the... on 2021-03-22. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1506-2021
Classification: Class III
Status: Open, Classified
Initiated: 2021-03-22
Posted: 2021-04-28
Recalling firm: Datascope Corp.
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
Product code: DSP System, Balloon, Intra-Aortic And Control
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).
Root cause tag: software
FDA 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 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.
Quantity in commerce: 10087 total
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2021	Class III	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-28
Z-1507-2021	Class III	Ongoing	Voluntary: Firm initiated	2021-05-05	2021-04-28

Product code DSP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)