Lower risk Medical device recall · FDA · Published November 4, 2025

Datascope Cardiosave Rescue Intra-Aortic Balloon Pump Recall: Preventative Maintenance

Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump systems with updated preventative maintenance schedule to align with June 2:2023 service manual changes.

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

🇺🇸 FDA recall #Z-0917-2026Medical device Datascope ›

Lower-risk recall

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump systems due to a revised preventative maintenance schedule that aligns with a June 2023 service manual update. This recall does not involve a safety hazard but requires updated maintenance procedures to ensure proper system function. Read more at govinfonow.com/recall/50724-datascope-cardiosave-rescue-intra-aortic-balloon-pump-recall-preventative-maintenance.

Source Summary by GovInfoNow · govinfonow.com/recall/50724-datascope-cardiosave-rescue-intra-aortic-balloon-pump-recall-preventative-maintenance · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0917-2026

Cite this page

“Datascope Cardiosave Rescue Intra-Aortic Balloon Pump Recall: Preventative Maintenance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50724-datascope-cardiosave-rescue-intra-aortic-balloon-pump-recall-preventative-maintenance. Based on FDA recall #Z-0917-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2026%22&limit=1).

The FDA announced on Nov. 4, 2025, that Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump system. The recall revises the preventative maintenance schedule to align with service manual updates from June 2023.

How to tell if you have it

Brand: Datascope
Product: Cardiosave Rescue Intra-Aortic Balloon Pump system
Model No. (UDI): 0998-00-0800-83 (10607567108407)
Serial No.: ALL
Units affected: 47

The hazard

The recall involves revising the Instructions for Use addendum to update the preventative maintenance schedule. This change aligns the schedule with an update introduced in the Service Manual as of June 2023.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls include a battery charging station recall on Feb. 6, 2026, and a CS100 IABP software update needed for safety on Jan. 23, 2026. Similar product recalls include the Fresenius Kabi Ivenix Infusion Pump recall on Nov. 3, 2025, and the ICU Medical Plum Solo IV Pump recall on Dec. 15, 2025.

How to tell if you have this one

Check for model number 0998-00-0800-83 or serial numbers listed in the recall notice. All units produced with this model number are affected.

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 II
Status
Ongoing
Distribution
Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.

Recall number	Product, codes & lots	Quantity
Z-0916-2026	Cardiosave Hybrid. Intra-Aortic Balloon Pump system.; Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.	11,470 units
Z-0917-2026	Cardiosave Rescue. Intra-Aortic Balloon Pump system.; Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.	47 units

Based on the official FDA remedy

What to do — step by step

Review Maintenance Schedule
Check the updated preventative maintenance schedule in the service manual to ensure timely maintenance.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, 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 43 days after the firm started it.

Nov 4, 2025Firm started the recall
Dec 11, 2025FDA classified it Class II
Dec 17, 2025Published 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 the pump?

No, the recall does not require stopping use; it only requires following the updated maintenance schedule.

What should I do with the pump?

No action is needed beyond reviewing the updated maintenance schedule as the system is safe for use.

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Link to this recall

<a href="https://govinfonow.com/recall/50724-datascope-cardiosave-rescue-intra-aortic-balloon-pump-recall-preventative-maintenance">Datascope Cardiosave Rescue Intra-Aortic Balloon Pump Recall: Preventative Maintenance (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-0917-2026 (November 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0917-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.