Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Recalled by Cardiac Assist, Inc Due to Epoxy used during manufacturing of the LifeSPARC Pump...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiac Assist, Inc directly.
Affected Products
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
Quantity: 2 units
Why Was This Recalled?
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiac Assist, Inc
Cardiac Assist, Inc has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report