Use caution Medical device recall · FDA · Published November 15, 2021

Datascope Cardiosave Rescue Pump Recall: Fluid Ingress Risk

Datascope recalls Cardiosave Rescue IntraAortic Balloon Pumps with specific model numbers due to risk of fluid entering the device, potentially causing system shutdown and unsafe hemodynamic instability.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0337-2022Medical device Datascope ›

Use caution until it’s fixed

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

Take action

Contact the company

Recalling firmDatascope Corp.1300 Macarthur Blvd · Mahwah, NJ 07430-2052

✎ GovInfoNow plain-language explainer

Datascope is recalling Cardiosave Rescue IntraAortic Balloon Pumps with model numbers 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, and others. Fluid entering the device could cause system shutdown, leading to unsafe blood pressure levels for patients. Read more at govinfonow.com/recall/61535-datascope-cardiosave-rescue-pump-recall-fluid-ingress-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61535-datascope-cardiosave-rescue-pump-recall-fluid-ingress-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0337-2022

Cite this page

“Datascope Cardiosave Rescue Pump Recall: Fluid Ingress Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61535-datascope-cardiosave-rescue-pump-recall-fluid-ingress-risk. Based on FDA recall #Z-0337-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0337-2022%22&limit=1).

The FDA announced on November 15, 2021, that Datascope Corp. is recalling Cardiosave Rescue IntraAortic Balloon Pumps due to the possibility of fluid ingress. Fluid entering the device may short electronic components and cause system shutdown, leading to unsafe hemodynamic instability.

How to tell if you have it

Brand: Datascope
Product: Cardiosave Rescue IntraAortic Balloon Pump
Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85
Serial Numbers: All Serial Numbers
Part Number: D998
Distribution: US Nationwide

The hazard

The recall addresses the possibility of fluid entering the device, which may short various electronic components and lead to system shutdown. This failure could result in unsafe hemodynamic instability for patients using the pump.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include Boston Scientific Intera 3000 Hepatic Artery Pump Recall (May 11, 2026), Fresenius Kabi Ivenix Infusion Pump Recall (November 3, 2025), and ICU Medical Plum Solo IV Pump Recall (April 29, 2026).

How to tell if you have this one

Check the model numbers on the pump: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, or 0998-UC-0800-85. The pump may also have serial numbers listed in the recall notice.

Brand
Datascope
Category
Medical device

FDA recall event · 2 products

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 I
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.

Recall number	Product, codes & lots	Quantity
Z-0336-2022	Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.; All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-65, 10607567113432	5,566 (US); 6,354 (OUS)
Z-0337-2022	Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.; All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.	44 (US); 5 (OUS)

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Look for model numbers on the pump: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, or 0998-UC-0800-85.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide.” 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 37 days after the firm started it.

Nov 15, 2021Firm started the recall
Dec 15, 2021FDA classified it Class I
Dec 22, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61535-datascope-cardiosave-rescue-pump-recall-fluid-ingress-risk">Datascope Cardiosave Rescue Pump Recall: Fluid Ingress Risk (GovInfoNow)</a>

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-0337-2022 (November 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0337-2022 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.