Recall Z-2440-2020— LivaNova Deutschland GmbH

Name: FDA recall Z-2440-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-26

Class II · Terminated

Class II FDA medical device recall by LivaNova Deutschland GmbH, initiated 2019-08-26, terminated 2021-04-22. It names one FDA 510(k) clearance: K011838. Product: Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986. Reason: The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome..

Recalling firm: LivaNova Deutschland GmbH
Classification: Class II
Status: Terminated
Initiated: 2019-08-26
Terminated: 2021-04-22
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K011838 — CENTRIFUGAL PUMPStockert Instrumente GmbH·cleared 2002-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986

Reason for recall

The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.

Data sourced from openFDA. This site is unofficial and independent of the FDA.