Events

Rappel de Device Recall VASOVIEW 6 Endoscopic Vessel Harvesting 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 Maquet Cardiovascular, LLC.

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
    59865
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3270-2011
  • Date de mise en oeuvre de l'événement
    2009-12-17
  • Date de publication de l'événement
    2011-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103887
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    During routine production quality monitoring process, it was found that uv curing adhesive was not used in a limited number of devices.
  • Action
    MAQUET Cardiovascular, LLC, sent an "Urgent Device Removal/Immediate Action Required" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.

Device

Device Recall VASOVIEW 6 Endoscopic Vessel Harvesting System
  • Modèle / numéro de série
    Part number: VH-2000; Lot # 9092171, Exp 8/31/2010
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: AL, AZ, CA, CT, FL, KS, KY, IL, IN, MI, MO, ND, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI.
  • Description du dispositif
    VASOVIEW 6 Endoscopic Vessel Harvesting System || Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. || Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Adresse du fabricant
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA