Events

Rappel de Boston Scientific brand Matrix 3D Omega Standard Coils

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 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538.

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
    57179
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0857-2011
  • Date de mise en oeuvre de l'événement
    2010-10-19
  • Date de publication de l'événement
    2011-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96009
  • 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
    Clamp, Uterine - Product Code HGC
  • Cause
    The product appears to have premature degradation of the pgla coating on the matrix coil.
  • Action
    US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.

Device

Boston Scientific brand Matrix 3D Omega Standard Coils
  • Modèle / numéro de série
    Material Product Description Catalog # Batch Numbers Expiry Date   M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012   Coils 1 Omm x 30cm  M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012   Coils 3mm x 6cm  M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012   Coils 4mm x 6cm  M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012   Coils 5mm x 8cm  M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012   Coils 5mm x 10cm
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
  • Description du dispositif
    Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
  • Manufacturer
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538

Manufacturer

Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
  • Adresse du fabricant
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA