Events

Recall of Sorin S5 Perfusionn System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group Deutschland GmbH.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66464
  • Event Risk Class
    Class 2
  • Event Number
    Z-0142-2014
  • Event Date Posted
    2013-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122435
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    Sorin group is recalling certain models of s5 perfusion systems due to malfunction of cardioplegia control.
  • Action
    Sorin Group sent an Urgent Field Safety Notice dated September 24, 2013, to all affected customers. The letter informed users of the potential for failing of automatic cardioplegia delivery function and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to update the firmware on site. Customers were asked to complete the Response form to confirm they had received, read and understood the Field Notice. For questions regarding this recall call 303-467-6527.

Device

Sorin S5 Perfusionn System
  • Model / Serial
    Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including WA, NY, VA, TN, SC, TX, CA, CO, MA, WI, MD, AL, ND, and Puerto Rico and Internationally to Italy, Finland, Germany, Sweden, and Great Britain.
  • Product Description
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. || The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH
  • Manufacturer Address
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA