Events

Rappel de Device Recall ProntoShort Extraction Catheter

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 Vascular Solutions, 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
    53938
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0547-2010
  • Date de mise en oeuvre de l'événement
    2009-11-20
  • Date de publication de l'événement
    2009-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86891
  • 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, embolectomy - Product Code DXE
  • Cause
    It was found that three pronto short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. the guidewire is sterilized separately and was realized to have an expiration date of october 31, 2009.
  • Action
    Vascular Solutions issued an "Urgent: Medical Device Recall - Lot Specific" notification dated November 20, 2009, via USPS. The letter described the issue, identified affected product, asked for affected devices to be removed from inventory, quarantine, and call customer service for a Return Authorization number. Units will be replaced upon Vascular Solutions (VSI) receiving the returned devices. A Product Recall Inventory form was asked to be completed and faxed back to VSI. For further information, contact your local sales representative or Vascular Solutions Director of Marketing at 1-763-656-4300.

Device

Device Recall ProntoShort Extraction Catheter
  • Modèle / numéro de série
    Lot Numbers: 544202, 545693 and 546614.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States (CA, CO, FL, GA, IA, IL, IN, KS, LA, MI, MO, NC, NE, NH, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA and WI), Canada, France, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Taiwan and Turkey.
  • Description du dispositif
    Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA