Use caution Medical device recall · FDA · Published September 8, 2021

Datascope Cardiosave IABP Recall: Risk of Unexpected Shutdown During AC Power Use

Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to risk of unexpected shutdown when running on AC power, potentially causing harm during critical medical use.

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

🇺🇸 FDA recall #Z-2615-2021Medical device Datascope ›

Use caution until it’s fixed

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Datascope is recalling specific Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) models because they can unexpectedly shut down when running on AC power if only one battery is installed and the battery is removed while charging. This hazard could cause serious harm during critical medical procedures. Read more at govinfonow.com/recall/61819-datascope-cardiosave-iabp-recall-risk-of-unexpected-shutdown-during-ac.

Source Summary by GovInfoNow · govinfonow.com/recall/61819-datascope-cardiosave-iabp-recall-risk-of-unexpected-shutdown-during-ac · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2615-2021

Cite this page

“Datascope Cardiosave IABP Recall: Risk of Unexpected Shutdown During AC Power Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61819-datascope-cardiosave-iabp-recall-risk-of-unexpected-shutdown-during-ac. Based on FDA recall #Z-2615-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2615-2021%22&limit=1).

The Food and Drug Administration announced on Sept. 8, 2021, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a hazard of unexpected shutdowns. The agency issued the recall for device Z-2615-2021.

How to tell if you have it

Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump, Model Nos. 0998-00-0800-31, 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 lots

The hazard

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since 2019-06-17. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06), GE Healthcare Carestation Anesthesia System Power Board Recall (2025-11-14), and Olympus UHI-4 Insufflation Unit Recall (2026-06-16).

How to tell if you have this one

Check for model numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, or 0998-00-0800-65. All lots of these models 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
Nationwide domestic distribution. Foreign distribution worldwide.

Recall number	Product, codes & lots	Quantity
Z-2615-2021	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 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 lots	3969 total (US), 3550 total (OUS)
Z-2616-2021	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; All lots	3969 total (US); 3550 total (OUS)

Based on the official FDA remedy

What to do — step by step

Check Battery Installation
Ensure the pump has two batteries installed and the battery is not removed while charging.
Verify Model Numbers
Confirm the model number matches the recalled list: 0998-00-0800-31 to 0998-00-0800-65.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide domestic distribution. Foreign distribution worldwide.” 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 28 days after the firm started it.

Sep 8, 2021Firm started the recall
Sep 30, 2021FDA classified it Class II
Oct 6, 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/61819-datascope-cardiosave-iabp-recall-risk-of-unexpected-shutdown-during-ac">Datascope Cardiosave IABP Recall: Risk of Unexpected Shutdown During AC Power Use (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-2615-2021 (September 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2615-2021 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.