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Use caution Medical device recall · FDA · Published July 31, 2023

Datascope Cardiosave Hybrid IABP Pumps: Gas Alarm Risk During Patient Movement

Datascope recalls specific Cardiosave Hybrid Intra-Aortic Balloon Pumps due to gas circuit alarms triggered by patient movement like coughing or swallowing, which could cause incorrect therapy alerts.

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

🇺🇸 FDA recall #Z-2435-2023Medical 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 certain Cardiosave Hybrid Intra-Aortic Balloon Pumps after reports of gas circuit alarms. These alarms can be triggered by normal patient movements such as coughing or swallowing, potentially leading to incorrect therapy alerts. Read more at govinfonow.com/recall/57557-datascope-cardiosave-hybrid-iabp-pumps-gas-alarm-risk-during-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/57557-datascope-cardiosave-hybrid-iabp-pumps-gas-alarm-risk-during-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2435-2023

Cite this page

“Datascope Cardiosave Hybrid IABP Pumps: Gas Alarm Risk During Patient Movement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57557-datascope-cardiosave-hybrid-iabp-pumps-gas-alarm-risk-during-patient. Based on FDA recall #Z-2435-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2435-2023%22&limit=1).

The FDA announced on July 31, 2023, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps due to potential alarm triggers not listed in the instructions for use. The agency issued recall number Z-2435-2023 for the Class I device.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
  • Part Numbers: 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, 0998-00-0800-45, 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
  • Lot Numbers: All Lot Numbers
  • Units affected: 9175

The hazard

According to the FDA, users reported instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation determined that patient movement, blood in the circuit, kinks and abrasions of the tubing/catheter, certain patient conditions, and hardware issues could trigger these alarms without being listed in the IFU.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion Pump Recall (Nov. 3, 2025), ICU Medical Plum Duo IV Pump Recall (April 29, 2026) and ICU Medical Plum Solo IV Pump Recall (April 29, 2026).

How to tell if you have this one

Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, or similar listed in the recall. Also look for the unique device identifiers (UDIs) provided in the record.

  • 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
    Worldwide - US Nationwide distribution.
Recall numberProduct, codes & lots
Z-2435-2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 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, 0998-00-0800-45, 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; All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Z-2436-2023Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Model

    Identify your pump model by checking the part number or unique device identifier (UDI) on the pump or packaging.

  2. Review Alarm History

    Check if your pump has triggered gas circuit alarms, especially during patient movement like coughing or swallowing.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide - 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 37 days after the firm started it.

1. Firm started the recall: Jul 31, 202312. FDA classified it Class I: Aug 30, 202323. Published in FDA’s Enforcement Report: Sep 6, 202332023
  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-2435-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2435-2023 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