Events

Rappel de Guider XF Softip Guide Catheter

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.

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
    53579
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0107-2010
  • Date de mise en oeuvre de l'événement
    2009-10-06
  • Date de publication de l'événement
    2009-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85902
  • 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
    Catheter, percutaneous - Product Code DQY
  • Cause
    Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
  • Action
    The firm initiated its 'Safety Alert' on October 6, 2009. A notification letter was sent to each customer reminding them to follow storage and handling instructions. The firm has not ceased distribution. Direct questions about this notification to the Boston Scientific Corporation at 1-510-624-1734.

Device

Guider XF Softip Guide Catheter
  • Modèle / numéro de série
    UPN/Model numbers: H965100420/10042, H965100430/10043, H965100440/10044, H965100460/10046, H965100470/10047, H965100480/10048, H965100500/10050, H965100510/10051, H965100520/10052, M003100620/10062, M003100630/10063, M003100640/10064, M003101420/10142, M003101430/10143, M003101440/10144, M003101460/10146, M003101470/10147, M003101480/10148, M003101500/10150, M003101510/10151, M003101520/10152, M003101620/10162, M003101630/10163 and M003101640/10164.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, UAE, Uruguay, Venezuela, Vietnam and Yemen.
  • Description du dispositif
    Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA. || The device is intended to facilitate placement of interventional devices into the neurovascular system.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 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