LifeSPARC Pump, LifeSPARC Controller

• • Ongoing Z-2465-2023 FDA Class II ·initiated 30 Jun 2023

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

• • Terminated Z-0926-2023 FDA Class I ·initiated 5 Dec 2022 ·via K183623, on the same 510(k)

  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.

• • Terminated Z-1763-2022 FDA Class I ·initiated 21 Jul 2022 ·via K183623, on the same 510(k)

  Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K183623 ↗

FDA Product Code

KFM

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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