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

Datascope Cardiosave Rescue IABP Recall: Coiled Cord Cable Shutdown Risk

Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with faulty Coiled Cord cable that may cause unexpected shutdowns. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. Contact for remedy.

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

🇺🇸 FDA recall #Z-1146-2023Medical deviceDatascope ›
Take action

Contact the company

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

Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps that have a Coiled Cord cable which may cause unexpected shutdowns. This could lead to medical complications if the pump fails during use. Read more at govinfonow.com/recall/58944-datascope-cardiosave-rescue-iabp-recall-coiled-cord-cable-shutdown-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58944-datascope-cardiosave-rescue-iabp-recall-coiled-cord-cable-shutdown-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1146-2023

Cite this page

“Datascope Cardiosave Rescue IABP Recall: Coiled Cord Cable Shutdown Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58944-datascope-cardiosave-rescue-iabp-recall-coiled-cord-cable-shutdown-risk. Based on FDA recall #Z-1146-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2023%22&limit=1).

The FDA announced on Feb. 7, 2023, that Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to an unexpected shutdown hazard. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
  • Part number: 0012-00-1801
  • Model Numbers: 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
  • Serial numbers: All serial numbers
  • Units affected: 4,062

The hazard

An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane. This failure disrupts communication between the display head and base unit.

Context

GovInfoNow's records show Datascope Corp. has issued 29 other recalls since June 17, 2019. Recent brand recalls include a Feb. 6, 2026, battery charging station recall for protruding screws and a Jan. 23, 2026, software update for safety specifications. Other recent recalls of similar products include a Jan. 9, 2026, Maquet Bubble Sensor recall for cable durability issues and a Dec. 4, 2025, Merit Medical Allwell Angioplasty Pack recall for handle detachment.

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. All serial numbers are affected. The part number 0012-00-1801 is also associated with this issue.

  • 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 Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, TURKMENISTAN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, AND YEMEN.
Recall numberProduct, codes & lots
Z-1145-2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, 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, 0998-00-0800-55; All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432
Z-1146-2023Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 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 for Model Numbers

    Identify if your pump has model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.

  2. Contact Datascope

    Reach out to Datascope Corp. for instructions on how to proceed with the recall.

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 Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE,…” 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 36 days after the firm started it.

1. Firm started the recall: Feb 7, 202312. FDA classified it Class I: Mar 9, 202323. Published in FDA’s Enforcement Report: Mar 15, 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-1146-2023 (February 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1146-2023 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