Events

Rappel de Device Recall NephroMax high Pressure nephrostomy Balloon Catheter Kit.

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
    65317
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1673-2013
  • Date de mise en oeuvre de l'événement
    2013-05-28
  • Date de publication de l'événement
    2013-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118544
  • 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
    Cather, Nephrostomy - Product Code LJE
  • Cause
    Incorrect sized renal sheath was packaged with the nephromax high pressure nephrostomy balloon catheter.
  • Action
    The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated May 28, 2013, consignees via Federal Express Priority Mail to its consignees/customers.OUS - Customer notification letters has also been sent to consignees/customers in the EU. The letter instructs the customers to Immediately discontinue use of and segregate recalled product; check their inventory; immediately remove all affected product from their inventory, and return it to Boston Scientific at Boston Scientific Corporation, US Distribution Center, Customer Fulfillment Center, 500 Commander Shea Blvd., Quincy, Massachusetts 02171 include original Verification Tracking Form and RGA #. The letter also requests the completion and return of the Account Reply Verification Tracking Form via email to: MapleGroveFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Follow up communications will be made to the customers that do not respond to this inquiry. Distributors are instructed to forward the recall notification to their customers. If you have any questions call 763-494-1133 or email to MapleGroveFieldActionCenter@bsci.com.

Device

Device Recall NephroMax high Pressure nephrostomy Balloon Catheter Kit.
  • Modèle / numéro de série
    Lot Number: 15982017, 15963887, 16034014
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
  • Description du dispositif
    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 || Dilation of the nephrostomy tract.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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