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

Datascope Cardiosave IABP Pumps Recall: Fiber Optic Sensor Failure Risk

Datascope recalls Cardiosave IABP pumps with specific part numbers due to potential fiber optic sensor failure during use. Affected units may have safety risks during medical procedures.

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

🇺🇸 FDA recall #Z-2487-2023Medical 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 specific Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) models because they can fail when inserting the fiber optic connector. This could lead to improper function during medical procedures, which is serious for patients needing this life-support device. Read more at govinfonow.com/recall/57563-datascope-cardiosave-iabp-pumps-recall-fiber-optic-sensor-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57563-datascope-cardiosave-iabp-pumps-recall-fiber-optic-sensor-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2487-2023

Cite this page

“Datascope Cardiosave IABP Pumps Recall: Fiber Optic Sensor Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57563-datascope-cardiosave-iabp-pumps-recall-fiber-optic-sensor-failure-risk. Based on FDA recall #Z-2487-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2487-2023%22&limit=1).

The FDA announced on July 31, 2023, that Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a sensor input failure during connector insertion. The agency issued the Class II recall affecting 9,379 units distributed nationwide and globally.

How to tell if you have it

  • Datascope Cardiosave Rescue Intra-Aortic Balloon Pump
  • 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

The hazard

According to the FDA, users experienced a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on file since June 17, 2019. Recent brand actions include a February 6, 2026 recall of the Battery Charging Station for protruding screws and a January 23, 2026 software update for CS300 IABP safety specifications. Other recent recalls of similar products include Intervascular Cardioroot Vascular Grafts (August 12, 2026), Fresenius Kabi Ivenix Infusion Pump (November 3, 2025), and Abiomed Impella RP (January 27, 2026).

How to tell if you have this one

Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. These models were sold with specific unique device identifiers (UDIs) 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-2486-2023Cardiosave 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-2487-2023Cardiosave 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 the pump model number by checking the label on the device.

  2. Contact Manufacturer

    Reach out to Datascope Corp. for guidance on whether your pump is affected and next steps.

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 37 days after the firm started it.

1. Firm started the recall: Jul 31, 202312. FDA classified it Class II: Aug 30, 202323. Published in FDA’s Enforcement Report: Sep 6, 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-2487-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2487-2023 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