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Lower risk Medical device recall · FDA · Published June 30, 2023

Cardiac Assist LifeSPARC Pump Recall: Uncured Epoxy May Cause Early Failure

Cardiac Assist recalls LifeSPARC Pumps with possible uncured epoxy that could lead to early pump failure. Affected units include specific part numbers and kit models sold between 2020-2022.

🇺🇸 FDA recall #Z-2465-2023Medical deviceCardiac Assist ›
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Contact the company

Recalling firmCardiac Assist, Inc240 Alpha Dr · Pittsburgh, PA 15238-2906
✎ GovInfoNow plain-language explainer

Cardiac Assist is recalling LifeSPARC Pumps that may contain uncured epoxy from manufacturing, which could cause early pump failure. This affects specific part numbers and kit models sold since 2020. If you own one of these models, contact the company for a replacement. Read more at govinfonow.com/recall/57759-cardiac-assist-lifesparc-pump-recall-uncured-epoxy-may-cause-early.

Source Summary by GovInfoNow · govinfonow.com/recall/57759-cardiac-assist-lifesparc-pump-recall-uncured-epoxy-may-cause-early · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2465-2023

Cite this page

“Cardiac Assist LifeSPARC Pump Recall: Uncured Epoxy May Cause Early Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57759-cardiac-assist-lifesparc-pump-recall-uncured-epoxy-may-cause-early. Based on FDA recall #Z-2465-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2465-2023%22&limit=1).

The FDA announced on June 30, 2023, that Cardiac Assist, Inc. is recalling LifeSPARC Pumps due to potential uncured epoxy that may cause early pump failure. Owners should contact the company for a remedy.

How to tell if you have it

  • LifeSPARC Pump (part number 5800-0000)
  • TandemLife LifeSPARC Priming Tray (part number 5800-1000)
  • UPC 00814112020609
  • Kit 5830-2916 with Pump Serial Number 00876971
  • Kit 5840-2417 with Pump Serial Number 00876972

The hazard

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. If undetectable, curing may result in an added risk of early pump failure.

Context

GovInfoNow's records show Cardiac Assist, Inc has 6 other recalls on record since 2019-11-19. Other recent recalls of similar products include AVID Medical Halyard CARDIAC CATH PACK SAN23CARDQ Kit Recall (2026-03-13), Abiomed Heart Pump Kit Recall (2026-06-11), and BD Alaris Infusion Pump Module 8100 Recall (2025-10-17).

How to tell if you have this one

Check for part number 5800-0000 in the LifeSPARC Pump or kit model numbers 5830-2916 and 5840-2417. These were sold between 2020 and 2022.

  • Brand
    Cardiac Assist
  • Product
    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for part number 5800-0000 on the pump or kit model numbers 5830-2916 and 5840-2417.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of IL, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Illinois.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jun 30, 202312. FDA classified it Class II: Aug 25, 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-2465-2023 (June 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2465-2023 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