Events

Rappel de Device Recall Boston Scientific Platinum Plus Guidewire

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
    49001
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2365-2008
  • Date de mise en oeuvre de l'événement
    2008-06-19
  • Date de publication de l'événement
    2008-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72497
  • 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
    Guidewire - Product Code DQX
  • Cause
    Boston scientific is initiating a voluntary recall of the platinum plus coronary guidewire. through our internal inspection process, we identified the potential that the ptfe (polytetrafluoroethylene) coating on the platinum plus coronary guidewires could be damaged in certain locations. this damage of the coating creates the potential for small particles of the ptfe coating to detach from the wi.
  • Action
    An urgent Voluntary medical Device Recall or Correction - Immediate Action Required letter was sent to all affected customers. The letter describes the issue and clinical effects. A list of affected devices is attached to the letter. The customer is to cease use or distribution of affected product, and return it immediately to Boston Scientific. Return directions are provided in an attached document. A Reply Verification Tracking Form is to be completed and faxed back to Customer Service. If any product is being returned the completed form is to accompany the returned product. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.

Device

Device Recall Boston Scientific Platinum Plus Guidewire
  • Modèle / numéro de série
    Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696, 8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162, 8432959, 8506417, 8533771, and 11643756.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • Description du dispositif
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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