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Use caution Medical device recall · FDA · Published February 7, 2023

Datascope Cardiosave IABP Pumps Risk Helium Leak - Recall

Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to potential helium regulator failure causing leaks and insufficient helium in the pump reservoir.

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

🇺🇸 FDA recall #Z-1230-2023Medical deviceDatascope ›
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Contact the company

Recalling firmDatascope Corp.1300 Macarthur Blvd · Mahwah, NJ 07430-2052
✎ GovInfoNow plain-language explainer

Datascope is recalling three specific models of Cardiosave Rescue Intra-Aortic Balloon Pumps because their helium regulator may fail, leading to helium leaks and insufficient helium in the pump reservoir. This could affect medical use if the pump isn't properly replenished during operation. Read more at govinfonow.com/recall/58933-datascope-cardiosave-iabp-pumps-risk-helium-leak-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/58933-datascope-cardiosave-iabp-pumps-risk-helium-leak-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1230-2023

Cite this page

“Datascope Cardiosave IABP Pumps Risk Helium Leak - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58933-datascope-cardiosave-iabp-pumps-risk-helium-leak-recall. Based on FDA recall #Z-1230-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1230-2023%22&limit=1).

The FDA announced on Feb. 7, 2023, that Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to potential helium leaks from regulator failures. The recall affects 8,909 units distributed nationwide and globally.

How to tell if you have it

  • Datascope Cardiosave Rescue Intra-Aortic Balloon Pump
  • Model Numbers: 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
  • All Serial Numbers

The hazard

According to the FDA, failures of the high pressure helium regulator may cause a helium leak in the Cardiosave Hospital Cart. This failure prevents the Pump Console's internal reservoir from being replenished when docked, resulting in insufficient helium.

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) and Fresenius Kabi Ivenix Infusion Pump Recall (Nov. 3, 2025).

How to tell if you have this one

Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. These models were sold with specific serial numbers and UDI-DI identifiers 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 II
  • Status
    Ongoing
  • Distribution
    US Nationwide. Global Distribution.
Recall numberProduct, codes & lots
Z-1229-2023Cardiosave 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, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55; All Serial Numbers. Model Number: 0998-00-0800-31, UDI-DI:10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-34, UDI-DI: 10607567111940; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432
Z-1230-2023Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85; All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449
Based on the official FDA remedy

What to do — step by step

  1. Check Model Numbers

    Identify the pump model number to confirm if it is one of the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Feb 7, 202312. FDA classified it Class II: Mar 6, 202323. Published in FDA’s Enforcement Report: Mar 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1230-2023 (February 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1230-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA