Events

Rappel de Boston Scientific brand Matrix2 360 Firm 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-0861-2011
  • 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=96013
  • 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
    vascular embolization device - 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 Matrix2 360 Firm Coils.
  • Modèle / numéro de série
    Material Product Description Catalog # Batch numbers Expiry Date    Matrix2¿ 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through  M0034941 030 494103 11640881,12009568,12102561,12229607,   30cm 12365838, 12366382 Jan2012  M0034941230 Matrix2¿ 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through   30cm 12026743, 12316656, 12636596 Apr2012   11244766,11336915,11456769,11484774,  M0034941430 Matrix2¿ 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through   30cm 11958454,12317003,12396265,12753164, Jan2013   13165081,13182077,13230095   11253266,11336717,11454608,11489048,  M0034941630 Matrix2¿ 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through   30cm 12176133,12214864,12319343,12396264, Dec2012   12859706, 13194482   11385269,11389724,11454839,11498643,  M0034941 830 Matrix2¿ 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through   30cm 12036898,12225706,12316657,12365837, Aug2012   12396263, 12854017, 12929266   Matrix2¿ 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through  M0034942030 494203 11766414,11766673,11958234,11999799,   30cm 12194742,12317006,12753163,12859707 Jul2012   11252232,11380482,11551322,11785187,   11785188,11785190,11785191,11785192,  M0034942440 Matrix2¿ 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through   40cm 11813608,11813609,11813610,11850841, Jul2012   12176108,12316654,12395388,12395420,   12428559,12429040,12841941,12861721  M0034945150 Matrix2¿ 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through   15cm Apr2012  M00349461 50 Matrix2¿ 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through   15cm Jul2011  M0034947200 Matrix2¿ 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through   20cm Apr2011  M0034948300 Matrix2¿ 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through   30cm Aug2011  M0034949300 Matrix2¿ 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through   30cm 12365839,12367860 Jan2012
  • 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 Matrix2 360 Firm 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