LifeSPARC 5900-0001

• • Ongoing Z-2465-2023 FDA Class II ·initiated 30 Jun 2023 ·via K183623, on the same 510(k)

  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

  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

  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.

Trade Name

LifeSPARC

Generic Name

Cardiopulmonary bypass system centrifugal pump drive unit

Model / Reference

5900-0001

Primary DI / UDI-DI

00814112020623

510(k) Number

K183623 ↗

K211830 ↗

FDA Product Code

DWA, QNR

GMDN Term

Cardiopulmonary bypass system centrifugal pump drive unit

Device Class

Class II

Regulation Number

870.4380, 870.4100

Commercial Distribution

Not in Commercial Distribution

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