Events

Rappel de Protg "GPS" SelfExpanding Biliary Stent System

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 Ev3, Inc..

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
    57112
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0626-2011
  • Date de mise en oeuvre de l'événement
    2010-10-30
  • Date de publication de l'événement
    2010-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95413
  • 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, biliary, diagnostic - Product Code FGE
  • Cause
    Mislabeled size: specific prot¿g¿ gps lots have product labeling that does not match the actual stent sizes contained in the packages. the affected product outer packaging is labeled as a 12 mm x 60 mm prot¿g¿ gps stent but contains a 14 mm x 60 mm stent. this situation can potentially result in vessel damage. conversely, a lot was labeled as a 14 mm x 60 mm prot¿g¿ gps stent but actually contai.
  • Action
    ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.

Device

Protg "GPS" SelfExpanding Biliary Stent System
  • Modèle / numéro de série
    Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
  • Description du dispositif
    ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. || ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Adresse du fabricant
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA