Cardiosave Rescue IABP - Product Usage: used to inflate and… recallZ-1507-2021 · Datascope Corp. · initiated Mar 22, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1507-2021
- Status
- Open, Classified
- Initiated by the company
- Mar 22, 2021
- Posted by the FDA
- Apr 28, 2021
- Recalling firm
- Datascope Corp.
- Quantity
- 10087 total
- Product code
- DSP
- FDA submissions
- K112372, K151254, K163542
- Distribution
- Worldwide distribution - US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
All Systems. UDI: 10607567112312 10607567108407 10607567113449
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- CARDIOSAVE RESCUE, CHINESE 0998-00-0800-75Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls12 reports
- CARDIOSAVE RESCUE, 3.1 EDITION 0998-00-0800-85Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 87482).
- Z-1506-2021 · Open, ClassifiedCardiosave 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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