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.
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.
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.
The software can freeze or crash during operation, causing the screen to stop displaying critical data. This may lead to improper blood pumping through the extracorporeal circuit during medical procedures, potentially causing serious complications.
Patients using the LifeSPARC system for extracorporeal blood circulation are most at risk. The affected units were sold starting in 2022 with specific serial numbers listed in the recall.
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.
Identify the model number on the device to see if it matches 5900-0000 or 5900-0001.
Install software update v1.1.5 to resolve the critical failure issue.
The recall applies to specific LifeSPARC Controller models (5900-0000 and 5900-0001) with the serial numbers listed in the recall notice. Check your device model and serial number to confirm.
Install software update v1.1.5 to prevent critical failures where the device freezes and stops displaying data.
The recall states that critical failures can occur, leading to improper blood pumping during medical procedures. However, the remedy involves a software update to address this, so the risk is manageable with the update.
We’ve drafted a message you can send Cardiac Assist to request your refund or repair — edit it as you like.
Subject: Recall Z-0926-2023 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-0926-2023 from Cardiac Assist. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
