Lower risk Medical device recall · FDA · Published September 8, 2021

Datascope Cardiosave IABP Recall: Helium Indicator May Overestimate Helium Levels

Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential helium indicator inaccuracies in electromagnetic interference.

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

🇺🇸 FDA recall #Z-0075-2022Medical device Datascope ›

Lower-risk recall

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

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 Pump models because the helium indicator might show more helium than actually present when exposed to electromagnetic interference. This could lead to incorrect pump settings during medical use. Read more at govinfonow.com/recall/61822-datascope-cardiosave-iabp-recall-helium-indicator-may-overestimate-helium-levels.

Source Summary by GovInfoNow · govinfonow.com/recall/61822-datascope-cardiosave-iabp-recall-helium-indicator-may-overestimate-helium-levels · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0075-2022

Cite this page

“Datascope Cardiosave IABP Recall: Helium Indicator May Overestimate Helium Levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61822-datascope-cardiosave-iabp-recall-helium-indicator-may-overestimate-helium-levels. Based on FDA recall #Z-0075-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0075-2022%22&limit=1).

The FDA announced on Sept. 8, 2021, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps because the helium indicator may overrepresent helium levels due to electromagnetic interference.

How to tell if you have it

Datascope 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

The hazard

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls include a Feb. 6, 2026, recall of the Datascope Battery Charging Station for protruding screws and a Jan. 23, 2026, software update for the CS300 IABP. Similar product recalls include a Jan. 13, 2026, Spectrum IQ Infusion Pump recall and April 29, 2026, recalls of ICU Medical Plum Duo and Solo IV pumps.

How to tell if you have this one

Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 on the pump. All lots of these models are included in the recall.

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
Worldwide distribution - US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-0075-2022	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	5054 total (US), 5033 total (OUS)
Z-0076-2022	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; All lots	5054 total (US); 5033 total (OUS)

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify the model number on your pump to see if it matches the recalled list.

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 35 days after the firm started it.

Sep 8, 2021Firm started the recall
Oct 7, 2021FDA classified it Class II
Oct 13, 2021Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More Datascope recalls

Link to this recall

<a href="https://govinfonow.com/recall/61822-datascope-cardiosave-iabp-recall-helium-indicator-may-overestimate-helium-levels">Datascope Cardiosave IABP Recall: Helium Indicator May Overestimate Helium Levels (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-0075-2022 (September 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0075-2022 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.