Events

Rappel de ATTAIN HYBRID Guide Wire

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 Medtronic Vascular.

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
    66567
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0265-2014
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • Date de publication de l'événement
    2013-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122628
  • 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
    Wire, guide, catheter - Product Code DQX
  • Cause
    Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
  • Action
    The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.

Device

ATTAIN HYBRID Guide Wire
  • Modèle / numéro de série
    0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including 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, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
  • Description du dispositif
    ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 || The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Adresse du fabricant
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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