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U.S. Department of Health and Human Services

Class 2 Device Recall Stockert Centrifugal Pump

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  Class 2 Device Recall Stockert Centrifugal Pump see related information
Date Initiated by Firm August 26, 2019
Create Date July 08, 2020
Recall Status1 Terminated 3 on April 22, 2021
Recall Number Z-2440-2020
Recall Event ID 85505
510(K)Number K011838  
Product Classification Control, pump speed, cardiopulmonary bypass - Product Code DWA
Product Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI:
04033817900986
Code Information Serial Number: 60S14838 60S14839 60S14829 60S14724 60S14850 60S14858 60S14732 60S14737 60S14844 60S14846 60S14854 60S14855 60S14777 60S14778 60S14725 60S14727 60S14784 60S14785 60S14845 60S14774 60S14775 60S14786 60S14830 60S14776 60S14882      
Recalling Firm/
Manufacturer		 LivaNova Deutschland GmbH
Lindberghstr. 25
Munich Germany
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 24
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWA and Original Applicant = STOCKERT INSTRUMENTE GMBH
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