Events

Rappel de Device Recall OptEase Vena Cava Filter

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 Cordis 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
    65482
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1887-2013
  • Date de mise en oeuvre de l'événement
    2013-03-29
  • Date de publication de l'événement
    2013-08-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119066
  • 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
    Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
  • Action
    Cordis Corporation sent an "URGENT Medical Device Correction" notification to their consignees in the US by letter dated April 3, 2013 and an e-mail was sent to the Canadian consignees. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to read the description and recommendations sections carefully, then sign and return the enclosed Acknowledgement Form directly to Cordis to their fax number(908) 429-8287 or Scan and e-mail to MiamiQA@crdus.jnj.com. The letter states to pass on the notice to anyone in the consignees' facilities that need to be informed. Additionally, the notification request consignees to maintain awareness of this notification until the information has been incorporated in the Cordis OPTEASE Vena Cava Filter labeling. For questions related to the issue contact Cordis Endovascular Medical Information Line 877-338-4235.

Device

Device Recall OptEase Vena Cava Filter
  • Modèle / numéro de série
    Model Numbers 466F220A and 466F220B.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama
  • Description du dispositif
    Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** || Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. || Product Usage: || The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Adresse du fabricant
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA