Reported Jan 25, 2023 · Terminated
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001.…
Cardiac Assist, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiac Assist, Inc · 240 Alpha Dr · Pittsburgh, PA · 15238-2906
Is this the product you have?
- SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
- Lot codes and dates
- Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers
589 of 589 codes
C00115C50232C50253C50403C00195C50619C50623C50161C50167C50362C50388C50432C50505C00189C50648C50437C50671C50690C00048C00087C50114C50135C00149C50274C50506C50308C50319C00040C00107C50207C50160C50016C50604C50493C50355C50633C00126C00155C50113C00041C00135C00042C00035C50012C50019C50073C00176C50386C50677C00052C00076C00092C50384C50490C50679C00095C50149C00182C50392C50337
- Model No. 5900-0000 - UDI/DI 00814112020562 Model No. 5900-0001 - UDI/DI 00814112020623 Serial Numbers
- Amount recalled
- 763 (US only)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cardiac Assist, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.