Events

Rappel de AGA AMPLATZER Vascular Plug

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 AGA Medical Corporation.

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
    33323
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0127-06
  • Date de mise en oeuvre de l'événement
    2005-09-01
  • Date de publication de l'événement
    2005-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-11-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41698
  • 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
    Device, Vascular, For Promoting Embolization - Product Code KRD
  • Cause
    Five lots of amplatzer vascular plugs were sterilized in a load that was not validated for the amplatzer vascular plug. however, only three of those five lots were distributed.
  • Action
    Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.

Device

AGA AMPLATZER Vascular Plug
  • Modèle / numéro de série
    The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
  • Description du dispositif
    AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Adresse du fabricant
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA