LivaNova Deutschland GmbH: Medical Device Recall in 2020 - (Recall #: Z-2439-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993

Product Classification:

Class II

Date Initiated: August 26, 2019

Date Posted: July 8, 2020

Recall Number: Z-2439-2020

Event ID: 85505

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.

Status: Terminated

Product Quantity: 8

Code Information:

Serial Number: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708

Distribution Pattern:

US: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA OUS: Canada - Uzbekistan - Turkey - Tunisia - Taiwan - South Africa - Serbia - Saudi Arabia - Russia - Poland - Mexico - Korea(Rep. of) - India - Hong Kong - Colombia - China - Brazil - Bahrain - Argentina - Algeria - Italy - Germany

Voluntary or Mandated:

Voluntary: Firm initiated