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Use caution Medical device recall · FDA · Published August 8, 2024

Datascope Cardiosave Hybrid IABP Recall: Risk of Hemodynamic Instability

Datascope recalls Cardiosave Hybrid IABP devices due to potential hemodynamic instability and clinical data transmission failure. Affected units include specific product numbers and UDI codes.

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

🇺🇸 FDA recall #Z-3134-2024Medical 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 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) because software issues could cause hemodynamic instability or failure to transmit clinical data. This recall affects medical devices used in critical care settings. Read more at govinfonow.com/recall/54251-datascope-cardiosave-hybrid-iabp-recall-risk-of-hemodynamic-instability.

Source Summary by GovInfoNow · govinfonow.com/recall/54251-datascope-cardiosave-hybrid-iabp-recall-risk-of-hemodynamic-instability · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3134-2024

Cite this page

“Datascope Cardiosave Hybrid IABP Recall: Risk of Hemodynamic Instability.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54251-datascope-cardiosave-hybrid-iabp-recall-risk-of-hemodynamic-instability. Based on FDA recall #Z-3134-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3134-2024%22&limit=1).

The FDA announced on Aug. 8, 2024, that Datascope Corp. is recalling Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices due to risks of hemodynamic instability and failure of clinical data transmission. The agency issued recall number Z-3134-2024 for the Class I voluntary recall.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Cardiosave Rescue Intra-Aortic Balloon Pump
  • Product Nos.: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
  • UDIs: 10607567109053, 10607567111117, 10607567109008, 10607567111940, 10607567109107, 10607567114187, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432
  • Lot No.: ALL LOTS
  • Units affected: 5,475

The hazard

The firm developed a software correction (Revision D.00) to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in the devices. The recall addresses issues with the electromechanical system used to inflate and deflate intra-aortic balloons.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Recent Datascope recalls include a Feb. 6, 2026, recall of the Battery Charging Station Model 0998-00-0802 for a protruding screw and a Jan. 23, 2026, software update for the CS300 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 Recall.

How to tell if you have this one

Check for product numbers starting with 0998-00-0800-31 to 0998-00-0800-65 or UDI codes listed in the recall notice. All lots 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 I
  • Status
    Ongoing
  • Distribution
    International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.
Recall numberProduct, codes & lots
Z-3134-2024CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.; Product No. 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65; UDI: 10607567109053, 10607567111117, 10607567109008, 10607567111940, 10607567109107, 10607567114187, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432; Lot No. ALL LOTS.
Z-3135-2024CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.; Product No. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; UDI: 10607567112312, 10607567108407, 10607567113449; Lot No. ALL LOTS.
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Verify your Cardiosave Hybrid IABP device model against the listed product numbers or UDI codes to confirm if it is affected.

  2. Contact Manufacturer

    Reach out to Datascope Corp. for guidance on software corrections or alternative solutions.

How this recall unfolded

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Aug 8, 202412. FDA classified it Class I: Sep 20, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  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-3134-2024 (August 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3134-2024 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