Events

Rappel de Perceval Sutureless Heart Valve

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Sorin Group USA, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75570
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0716-2017
  • Date de mise en oeuvre de l'événement
    2016-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150822
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    heart-valve, non-allograft tissue - Product Code LWR
  • Cause
    Sorin group usa, inc. announces a voluntary field action for the perceval sutureless heart valve due to updated steps associated with the implantation procedure.
  • Action
    The firm, LivaNova, sent a "Customer Letter" dated 10/31/2016 to its Consignees with clarifications about the implant of the Perceval Sutureless Aortic Valve. The letter described the product, problem and actions to be taken. The consignees were instructed to reinforce the steps that may influence procedural success and mitigate potential complications and complete and return the Customer Response Form via fax to: LivaNova Canada Corp, Canada at +1 303 895 2335 or email to: HV.FEEDBACK@LIVANOVA.COM. If you have additional questions or request of clarifications, please contact your LivaNova representative or Customer Service. For questions regarding this customer letter, please contact your LivaNova sales representative or email: hv.feedback@livanova.com.

Device

Perceval Sutureless Heart Valve
  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait, Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
  • Description du dispositif
    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. || The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA