Events

Rappel de Device Recall Medtronic EnVeo R Loading System

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 Medtronic Cardiovascular Surgery-the Heart Valve Division.

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
    71719
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2264-2015
  • Date de mise en oeuvre de l'événement
    2015-07-15
  • Date de publication de l'événement
    2015-08-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138827
  • 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
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Cause
    Medtronic is recalling the enveo r loading systems because of the presence of particulate.
  • Action
    An Urgent Medical Device Recall Letter dated July 2015 will be be sent to customers who purchased the EnVeo R Loading System because Medtronic has received 8 reports related to this issue out of 7347 potentially affected units. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.

Device

Device Recall Medtronic EnVeo R Loading System
  • Modèle / numéro de série
    0007254814 0007266413 0007332504 0007332506 0007332508 0007332510 0007343321 0007343324 0007343327 0007350825 0007350837 0007354113 0007354245 0007366949 0007369883 0007393098 0007393101 0007408862 0007408865 0007408867 0007408869 0007428258 0007428260 0007428263 0007435169 0007439358 0007439360 0007439362 0007456292 0007456298 0007462901 0007462903 0007462905 0007476215 0007476217 0007476219 0007482219 0007482222 0007482226 0007486826 0007492356 0007495691 0007495694 0007495696 0007508883 0007508885 0007508891 0007515698 0007515700 0007515703 0007522595 0007522598 0007522600 0007522603 0007530963 0007530973 0007537892 0007537894 0007569474 0007569477 0007569482 0007573778 0007573785 0007573788 0007573791 0007579940 0007579944 0007579948 0007579951 0007592664 0007592666 0007592669 0007592672 0007598984
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
  • Description du dispositif
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
  • Manufacturer
    Medtronic Cardiovascular Surgery-the Heart Valve Division

Manufacturer

Medtronic Cardiovascular Surgery-the Heart Valve Division
  • Adresse du fabricant
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA