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Open, Classified

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

FDA Recall Z-2465-2023 · Posted 2023-08-25

Recalling FirmCardiac Assist, Inc
Recall StatusOpen, Classified
Product CodeKFM
Date Initiated2023-06-30
Product Quantity2 units

Reason for Recall

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Firm Action

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of IL, FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 2019-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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