Reported Oct 5, 2022 · Terminated
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 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?
- TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
- Lot codes and dates
- Model 5900-0000 - UDI-DI00814112020562
- Model 5900-0001 - UDI-DI
554 of 554 codes
00814112020623 Serial No.: C00115C50232C50253C50403C00195C50619C50623C50161C50167C50388C50432C50505C00189C50437C50671C50690C50362C50648C00048C00087C00149C50274C50506C50308C50319C00040C00107C50160C50016C50604C50493C50355C00126C00155C50113C00041C00135C00042C00035C50012C50019C00176C50386C00052C00076C00092C50490C00095C50149C00182C50392C50337C50451C50306C50460C50512C50082C50092C50174C00151
- Amount recalled
- 723 units (484 currently in field)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Critical Failure of the LifeSPARC controller when 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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