Events

Rappel de Device Recall Greenfield Vena Cava Filter 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 Boston Scientific.

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
    34134
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0280-06
  • Date de mise en oeuvre de l'événement
    2005-12-02
  • Date de publication de l'événement
    2005-12-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43177
  • 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
    Filter, Intravascular, Cardiovascular - Product Code DTK
  • Cause
    There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the greenfield vena cava filters with 12 fr femoral introducer systems manufactured before marcyh 10, 2004. if the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
  • Action
    Recall packages started going out 12/02/05 via Fed Ex and was completed 12/03/05. A letter was directed to several persons within each hospital . The letter describes the issues, the affected lot numbers and the complaints that Boston Scientific has received. Affected devices are to be segregated for return back to Boston Scientific. A 'Reply Verification Tracking Form' is asked to be returned back to Boston Scientific.

Device

Device Recall Greenfield Vena Cava Filter System
  • Modèle / numéro de série
    all codes of product manufactured before March 10, 2004. Catalog no. 50-501 with lot/batch # between 5145758 and 6387904
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    nationwide (except ND); Virgin Islands, OUS to include: united Arab Emirates, Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Chile, China, Colombia, Germany, Spain, France, Ireland, Great Britain, Israel, India, Italy, Jamaica, Jordan, Japan, Korea (South Republic), Kuwait, Lebanon, Mexico, Malaysia, Netherlands, New Zealand, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Taiwan, Venezuela
  • Description du dispositif
    Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter.
  • Manufacturer
    Boston Scientific

Manufacturer

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