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

Datascope Cardiosave Hybrid Pump Recall: O-ring leaks risk therapy interruption

Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to damaged O-rings causing helium leaks that may interrupt therapy. Affected units include D998-00-0800-31 to D998-UC-0800-55.

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

🇺🇸 FDA recall #Z-1231-2023Medical 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 Cardiosave Hybrid Intra-Aortic Balloon Pumps with certain model numbers because worn or torn O-rings can cause helium leaks. If the helium supply runs out, the medical therapy stops, which could be dangerous for patients using the device. Read more at govinfonow.com/recall/58935-datascope-cardiosave-hybrid-pump-recall-o-ring-leaks-risk-therapy.

Source Summary by GovInfoNow · govinfonow.com/recall/58935-datascope-cardiosave-hybrid-pump-recall-o-ring-leaks-risk-therapy · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1231-2023

Cite this page

“Datascope Cardiosave Hybrid Pump Recall: O-ring leaks risk therapy interruption.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58935-datascope-cardiosave-hybrid-pump-recall-o-ring-leaks-risk-therapy. Based on FDA recall #Z-1231-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1231-2023%22&limit=1).

The FDA announced on Feb. 7, 2023, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps due to helium tank leaks caused by damaged O-rings. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Hybrid Intra-Aortic Balloon Pump
  • Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55
  • Units affected: 11,792

The hazard

The firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since 2019-06-17. Other recent recalls include a Datascope Battery Charging Station recall on 2026-02-06 and a Datascope CS100 IABP software update needed for safety on 2026-01-23. Similar product recalls include a Medtronic Perfusion Systems EOPA Cannula recall on 2026-06-24, a Merit Medical Allwell Angioplasty Pack recall on 2025-12-04, and a Boston Scientific Intera 3000 Hepatic Artery Pump recall on 2026-05-11.

How to tell if you have this one

Check the model number on your Cardiosave Hybrid pump. Affected units have model numbers starting with D998-00-0800 or D998-UC-0800, specifically D998-00-0800-31 through D998-UC-0800-55 as 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
    Nationwide US distribution. Worldwide international distribution.
Recall numberProduct, codes & lotsQuantity
Z-1231-2023Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.; Model Number (UDI-DI): D998-00-0800-31 (10607567109053¿), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-00-0800-83 (10607567108407), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414). All serial numbers11,792 units (5.408 US, 6,384 OUS)
Z-1232-2023Cardiosave Rescue. Model Number: 0998-00-0800-83.; Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.47 units (44 US, 3 OUS)
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for the model number on your pump, which should be one of the listed numbers starting with D998-00-0800 or D998-UC-0800.

  2. Contact Datascope

    Reach out to Datascope Corp. to confirm if your pump is affected and get instructions for next steps.

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: “Nationwide US distribution. Worldwide international 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 36 days after the firm started it.

1. Firm started the recall: Feb 7, 202312. FDA classified it Class II: Mar 6, 202323. Published in FDA’s Enforcement Report: Mar 15, 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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What model numbers are affected?

The affected model numbers are D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, and D998-UC-0800-55.

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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-1231-2023 (February 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1231-2023 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