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

Datascope Cardiosave Hybrid: Unexpected IABP Shutdown Risk

Datascope recalls Cardiosave Hybrid models 0998-00-0800-31 to 0998-00-0800-65 due to potential IABP shutdown causing therapy interruption and hemodynamic instability.

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

🇺🇸 FDA recall #Z-1147-2023Medical 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 Hybrid models because a communication failure between internal components could cause sudden shutdown of the device, potentially interrupting life-support therapy and risking patient hemodynamic stability without the user being aware. Read more at govinfonow.com/recall/58937-datascope-cardiosave-hybrid-unexpected-iabp-shutdown-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58937-datascope-cardiosave-hybrid-unexpected-iabp-shutdown-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1147-2023

Cite this page

“Datascope Cardiosave Hybrid: Unexpected IABP Shutdown Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58937-datascope-cardiosave-hybrid-unexpected-iabp-shutdown-risk. Based on FDA recall #Z-1147-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1147-2023%22&limit=1).

The FDA announced on Feb. 7, 2023, that Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to an unexpected shutdown hazard. The agency said the devices may lose communication between components, interrupting therapy and threatening patient stability.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Hybrid
  • Model Nos.: 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*
  • Units: 4793 in the US; 4407 outside the US

The hazard

The FDA said an unexpected shutdown of the intra-aortic balloon pump may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This interruption to therapy may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls include a Datascope Battery Charging Station recall on Feb. 6, 2026, and a Datascope CS100 IABP software update needed on Jan. 23, 2026. Other recent recalls of similar products include a Fresenius Kabi Ivenix Infusion System Software Recall on May 6, 2026.

How to tell if you have this one

Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 on the device. The recall includes specific serial numbers listed in the official 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 Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV; and OUS (Foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELRUS, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE,GERMANY,GHANA,GUATEMALA,HONG KONG,HUNGARY,ICELAND,INDIA,INDONESIA IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM UZBEKISTAN, VIETNAM, YEMEN AND ZAMBIA.
Recall numberProduct, codes & lots
Z-1147-2023Cardiosave Hybrid Model Nos. 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* * -- not distributed in US; Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432 0998-UC-0800-31* N/A 0998-UC-0800-33* N/A 0998-UC-0800-52* N/A 0998-UC-0800-53* N/A 0998-00-0800-55* N/A All serial numbers
Z-1148-2023Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85; Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serial numbers
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify if the device is functioning properly by observing for unexpected shutdowns or therapy interruptions.

  2. Contact Manufacturer

    Reach out to Datascope Corp. for further guidance on device status and potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

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 8, 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-1147-2023 (February 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1147-2023 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