Events

Rappel de Device Recall Platinum Plus

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
    49462
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0030-2009
  • Date de mise en oeuvre de l'événement
    2008-08-25
  • Date de publication de l'événement
    2008-10-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73479
  • 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 guidewire (peripheral). bsc has received reports that product may be labeled as a 260 cm long guidewire when the actual packaged device is a 180 cm long guidewire and the product may be labeled as a 180 cm long guidewire when the actual packaged device is a 260 cm long guidewire. there is no expected potential for injury to.
  • Action
    A "Boston Scientific Urgent Voluntary Medical Device Recall or Correction - Immediate Action Required" letter dated 8/25/08 was sent to each affected account (To The Hospital Field Action Contact). The letter includes the customer steps for recall, a complete listing of all product batches/lots being recalled, the Reply Verification Tracking Form(s), and a return shipping label. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.

Device

Device Recall Platinum Plus
  • Modèle / numéro de série
    Lot # 11574626
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA: CA FL GA IL IN LA MN MO NJ NV NY OH PA TN TX UT WA WI and WV OUS: France, Germany, Great Britain, Italy, and the Netherlands.
  • Description du dispositif
    Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
  • 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