LifeSPARC Pump (part number 5800-0000) contained within T... (Cardiac Assist, Inc) – epoxy used during manufacturing of th... (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Cardiac Assist, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972
Cardiac Assist, Inc is recalling LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part numbe due to Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Recommended Action
Per FDA guidance
LivaNova - TandemLife made Initial contact by phone/email on June 30,2023 to ensure the affected pumps were quarantined and not used. Other details of the recall, including how the customer is to respond, are included in the customer letter issued July 14, 2023 provided via regular mail and/or email. Letter states reason for recall, health risk and action taken. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026