Use caution Medical device recall · FDA · Published December 19, 2022

Datascope Cardiosave Hybrid IABP Recall: Risk of Unexpected Shutdown Due to Blood Entry

Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdown from blood entering the device during therapy with a compromised catheter.

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

🇺🇸 FDA recall #Z-0885-2023Medical device Datascope ›

Use caution until it’s fixed

The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) models because they may shut down unexpectedly if blood enters the device while using a compromised catheter. This could lead to treatment interruptions for patients needing cardiac support. Read more at govinfonow.com/recall/59091-datascope-cardiosave-hybrid-iabp-recall-risk-of-unexpected-shutdown-due.

Source Summary by GovInfoNow · govinfonow.com/recall/59091-datascope-cardiosave-hybrid-iabp-recall-risk-of-unexpected-shutdown-due · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0885-2023

Cite this page

“Datascope Cardiosave Hybrid IABP Recall: Risk of Unexpected Shutdown Due to Blood Entry.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/59091-datascope-cardiosave-hybrid-iabp-recall-risk-of-unexpected-shutdown-due. Based on FDA recall #Z-0885-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0885-2023%22&limit=1).

The FDA announced on Dec. 19, 2022, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps because the device may shut down unexpectedly if blood enters the pump during therapy with a compromised catheter.

How to tell if you have it

Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65
All Serial Numbers
Part number D998
11,906 units

The hazard

The Cardiosave IABP may shut down unexpectedly due to blood entering the device when therapy is provided with a compromised intra-aortic balloon catheter.

Context

GovInfoNow's records show Datascope Corp. has had 29 other recalls since June 17, 2019. Recent brand recalls include a Feb. 6, 2026, recall of the Battery Charging Station for protruding screws and a Jan. 23, 2026, software update for the CS100 IABP. Other recent recalls of similar products include the Nov. 3, 2025, Fresenius Kabi Ivenix Infusion Pump recall and the Dec. 15, 2025, ICU Medical Plum Solo IV Pump and Plum Duo Infusion Pump recalls.

How to tell if you have this one

Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 or 0998-UC-0800-31 through 0998-UC-0800-65. All serial numbers are also affected. The device may also be designated as part number D998.

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 and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA and HERZEGOVINA, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d'Ivoire, Croatia, CZECH REPUBLIC, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, TRINIDAD AND TOBAGO, Tunisia, Turkey, Turkmenistan, Ukraine, UNITED ARAB EMIRATES, United Kingdom, Vietnam, Yemen, and Zambia.

Recall number	Product, codes & lots	Quantity
Z-0885-2023	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 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; 0998-00-0800-32, 10607567111117; 0998-00-0800-33, 10607567109053; 0998-00-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-31, 10607567109053; 0998-UC-0800-32, 10607567111117; 0998-UC-0800-33, 10607567109008; 0998-UC-0800-34, 10607567111940; 0998-UC-0800-35, 10607567109107; 0998-UC-0800-36, 10607567114187; 0998-UC-0800-45, 10607567108421; 0998-UC-0800-52, 10607567108438; 0998-UC-0800-53, 10607567108391; 0998-UC-0800-55, 10607567108414; 0998-UC-0800-65, 10607567113432.	11,906 Total
Z-0886-2023	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 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; 0998-00-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-75, 10607567112312; 0998-UC-0800-83, 10607567108407; 0998-UC-0800-85, 10607567113449.	46 Total

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on your Cardiosave IABP device to confirm if it is in the recalled list.
Contact Manufacturer
Reach out to Datascope Corp. for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution - US Nationwide and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA and HERZEGOVINA, Brazil, Brunei, Bulgaria, Canada, Chile,…” 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.

Dec 19, 2022Firm started the recall
Jan 19, 2023FDA classified it Class I
Jan 25, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this device immediately?

The recall does not require immediate stop use; however, affected users should check with Datascope Corp. for guidance.

Similar recalls

Latest medical device recalls

Keep exploring

More Datascope recalls

Link to this recall

<a href="https://govinfonow.com/recall/59091-datascope-cardiosave-hybrid-iabp-recall-risk-of-unexpected-shutdown-due">Datascope Cardiosave Hybrid IABP Recall: Risk of Unexpected Shutdown Due to Blood Entry (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-0885-2023 (December 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0885-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.