Events

Recall of Device Recall AMPLATZER Exchange Systems

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
    30481
  • Event Risk Class
    Class 2
  • Event Number
    Z-0363-05
  • Event Initiated Date
    2004-11-23
  • Event Date Posted
    2004-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36298
  • 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
    unknown device name - Product Code GBK
  • Reason
    Tubing utilized in the manufacture of the amplatzer delivery and exchange system sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
  • Action
    Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.

Device

Device Recall AMPLATZER Exchange Systems
  • Model / Serial
    M01L12-10, M03D08-06, M03D08-07, M03L18-54
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Product Description
    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Manufacturer Address
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA