LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

The firm issued an Urgent Field Safety Notice, SCP Control panel (Subset) dated August 29, 2019 via USPS on August 29, 2019 to inform consignees that LivaNova is executing a voluntary medical device correction a limited subset of SCP control panels (references 60-02-15 & 60-02-50) due to an observed trend in reported complaints. The letter describes immediate action to be taken by customers. It states: LivaNova is initiating the proactive replacement of potentially affected angle encoder lots in the field in order to reduce the likelihood of the occurrence of the above described issue. Actions to be taken by the Customer/User Pending the replacement of affected angle encoder(s) would be completed, LivaNova is kindly requesting SCP system users to take the following actions, without any delay: 1. Affected SCP control panel(s) listed in Attachment 1 should be quarantined. Your LivaNova representative may support you in this activity (refer to contact reference person at the end of this letter). 2. In case of urgent medical need, affected devices could be used, provided the SCP system operating instructions would be strictly followed, especially safety instructions related to the pump operation. Users should: a. ensure to have a SCP emergency drive unit ready for use, b. be familiar with the mounting as well as the functioning of the emergency drive unit. As reported in the operating instructions, hand cranking remains an option in case it would become necessary to operate the SCP manually. 3. Please complete and return the Customer Response Form (Attachment 2) by e-mail to LivaNova.FSCA@livanova.com. For questions regarding this Field Safety Notice, please contact your LivaNova representative, or LivaNova Customer Quality organization at LivaNova.FSCA@livanova.com. A copy of this letter has been provided to the U.S. Food and Drug Administration (FD

Distribution

As reported by FDA

FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA