Use caution Medical device recall · FDA · Published December 5, 2022

Cardiac Assist LifeSPARC Controller Software Update Recalled for Critical Failure Risk

Cardiac Assist recalls LifeSPARC Controller models 5900-0000 and 5900-0001 due to software freezing and data display issues that could cause critical failure during use.

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

🇺🇸 FDA recall #Z-0926-2023Medical device Cardiac Assist ›

Use caution until it’s fixed

A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

Take action

Contact the company

Recalling firmCardiac Assist, Inc240 Alpha Dr · Pittsburgh, PA 15238-2906

✎ GovInfoNow plain-language explainer

Cardiac Assist is recalling two LifeSPARC Controller models (5900-0000 and 5900-0001) because a software update (v1.1.5) is needed to prevent critical failures where the device freezes and stops displaying data. This could lead to improper blood pumping during medical procedures. Read more at govinfonow.com/recall/59241-cardiac-assist-lifesparc-controller-software-update-recalled-for-critical-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/59241-cardiac-assist-lifesparc-controller-software-update-recalled-for-critical-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0926-2023

Cite this page

“Cardiac Assist LifeSPARC Controller Software Update Recalled for Critical Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59241-cardiac-assist-lifesparc-controller-software-update-recalled-for-critical-failure. Based on FDA recall #Z-0926-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2023%22&limit=1).

Cardiac Assist, Inc recalled LifeSPARC controllers and accessories via the FDA on Dec. 5, 2022, due to a software critical failure hazard. The agency announced the Class I recall of model numbers 5900-0000 and 5900-0001.

How to tell if you have it

Brand: Cardiac Assist
Product: SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001
Model No. 5900-0000 - UDI/DI 00814112020562
Model No. 5900-0001 - UDI/DI 00814112020623
Serial Numbers: C00115 through C00209 (full list in record)
Quantity: 763 units

The hazard

The hazard involves a Critical Failure where the software freezes or crashes and the screen does not display data. This issue was first addressed in a recall initiated July 21, 2022.

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 HeartMate 3 System Controller Recall (2026-05-13) and Thoratec HeartMate 3 LVAS Kits Recall (2026-05-13).

How to tell if you have this one

Check for model numbers 5900-0000 or 5900-0001 on the device. The affected units have specific serial numbers listed in the recall notice, including many starting with 'C' or '5' followed by numbers.

Brand
Cardiac Assist
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the device to see if it matches 5900-0000 or 5900-0001.
Install Software Update
Install software update v1.1.5 to resolve the critical failure issue.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Dec 5, 2022Firm started the recall
Jan 19, 2023FDA classified it Class I
Jan 25, 2023Published in FDA’s Enforcement Report
Aug 8, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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More Cardiac Assist recalls

Link to this recall

<a href="https://govinfonow.com/recall/59241-cardiac-assist-lifesparc-controller-software-update-recalled-for-critical-failure">Cardiac Assist LifeSPARC Controller Software Update Recalled for Critical Failure Risk (GovInfoNow)</a>

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-0926-2023 (December 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0926-2023 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.