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

Datascope Cardiosave IABP Pumps Not Charging Due to Console Misplacement

Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to battery charging issues when the console isn't fully inserted into the hospital cart.

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

🇺🇸 FDA recall #Z-2431-2023Medical 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 because users may not be charging properly if the console isn't fully inserted into the hospital cart. This could lead to the device not functioning correctly during medical use. Read more at govinfonow.com/recall/57556-datascope-cardiosave-iabp-pumps-not-charging-due-to-console-misplacement.

Source Summary by GovInfoNow · govinfonow.com/recall/57556-datascope-cardiosave-iabp-pumps-not-charging-due-to-console-misplacement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2431-2023

Cite this page

“Datascope Cardiosave IABP Pumps Not Charging Due to Console Misplacement.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57556-datascope-cardiosave-iabp-pumps-not-charging-due-to-console-misplacement. Based on FDA recall #Z-2431-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2431-2023%22&limit=1).

The FDA announced on July 31, 2023, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps because users were unaware the console was not fully inserted into the hospital cart, preventing the battery from charging. The agency issued recall number Z-2431-2023 for the voluntary Class I recall.

How to tell if you have it

  • Datascope Cardiosave Hybrid Intra-Aortic Balloon Pumps
  • 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
  • 9175 units distributed worldwide and US Nationwide

The hazard

The FDA said users reported the device was not charging as expected. It was discovered that the Cardiosave console was not completely inserted into the hospital cart, which prevents the battery from charging.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include Datascope Battery Charging Station Model 0998-00-0802 Recall (Feb. 6, 2026), Datascope CS100 IABP Software Update Needed for Safety (Jan. 23, 2026), and Datascope Cardiosave Rescue Intra-Aortic Balloon Pump Recall (Nov. 4, 2025). Other recent recalls of similar products include ICU Medical Plum Duo IV Pump Recall (Dec. 15, 2025), ICU Medical Plum Solo IV Pump Recall (Dec. 15, 2025), and ICU Medical Plum Duo Infusion Pump Recall (Dec. 15, 2025).

How to tell if you have this one

Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and other listed models. The device was sold with specific lot numbers and unique identifiers (UDIs) as detailed 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 I
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution.
Recall numberProduct, codes & lots
Z-2431-2023Cardiosave 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-2432-2023Cardiosave 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 Console Insertion

    Ensure the Cardiosave console is fully inserted into the hospital cart before use to allow proper battery charging.

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-2431-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2431-2023 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