Events

Rappel de Device Recall Sizing Balloon II

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 AGA Medical 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
    57819
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1595-2011
  • Date de mise en oeuvre de l'événement
    2010-12-17
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97502
  • 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, intravascular occluding, temporary - Product Code MJN
  • Cause
    Aga medical is initiating a voluntary recall of a specific lot of mislabeled amplatzer sizing balloon ii. aga medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. the proper sizing (24 mm) was printed on the device hub visible through the product package.
  • Action
    AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA. For questions regarding this recall call 1-763-531-3175.

Device

Device Recall Sizing Balloon II
  • Modèle / numéro de série
    Lot 10004282114
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom
  • Description du dispositif
    AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. || The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Adresse du fabricant
    AGA Medical Corporation, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA