Datascope Cardiosave Rescue IABP Recall: Cybersecurity Risk to Hospital Systems
Datascope recalls Cardiosave Rescue IABP devices due to cybersecurity vulnerabilities that could disrupt hospital information systems. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. No remedy is specified in the recall notice.
Recall notice
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).
Contact the company
What happened, in plain English
Datascope is recalling Cardiosave Rescue IABP devices that use intra-aortic balloons for heart support. The recall is due to cybersecurity vulnerabilities in the software that could disrupt hospital information systems. This affects hospital equipment, not end-users directly. Read more at govinfonow.com/recall/63012-datascope-cardiosave-rescue-iabp-recall-cybersecurity-risk-to-hospital-systems.
Source Summary by GovInfoNow · govinfonow.com/recall/63012-datascope-cardiosave-rescue-iabp-recall-cybersecurity-risk-to-hospital-systems · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1507-2021
Cite this page
“Datascope Cardiosave Rescue IABP Recall: Cybersecurity Risk to Hospital Systems.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63012-datascope-cardiosave-rescue-iabp-recall-cybersecurity-risk-to-hospital-systems. Based on FDA recall #Z-1507-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1507-2021%22&limit=1).
Why it’s dangerous
The devices use a low-level TCP/IP software library with cybersecurity vulnerabilities. If exploited, this could cause loss of communication with hospital information systems, potentially disrupting patient care and medical records.
Who’s affected
Hospitals and healthcare facilities using the Cardiosave Rescue IABP devices are affected. Medical staff and patients using these devices may be at risk if the hospital information systems are disrupted.
How to tell if you have this one
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. The recall applies to all systems that use these models.
- Brand
Datascope- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide distribution.
| Recall number | Product, codes & lots |
|---|---|
| Z-1506-2021 | 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; All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432 |
| Z-1507-2021 | 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; All Systems. UDI: 10607567112312 10607567108407 10607567113449 |
What to do — step by step
Check Device Model
Identify the model number on the device to confirm if it is one of the recalled models.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1507-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1507-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.