Events

Recall of Device Recall Amplatzer TorqVue Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGA Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54369
  • Event Risk Class
    Class 2
  • Event Number
    Z-1101-2010
  • Event Initiated Date
    2009-12-18
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88348
  • Notes / Alerts
    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.
  • Extra notes in the data
    vascular introducer - Product Code DQY
  • Reason
    In this lot of torqvue delivery systems (pn: 9-itv10f45/80, ln: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.
  • Action
    An AGA Medical Product Recall Notice, dated December 18, 2009 was sent to customers on 12/18/2009. The letter identified the affected product, described the issue and asked for devices to be returned. Customers are asked to complete a form attached to the product recall notice and return it to AGA via fax or email.

Device

Device Recall Amplatzer TorqVue Delivery System
  • Model / Serial
    Lot 0906151781
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.
  • Product Description
    AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Manufacturer Address
    AGA Medical Corporation, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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