Events

Recall of Device Recall iCAST and Advanta

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atrium 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
    77342
  • Event Risk Class
    Class 2
  • Event Number
    Z-2761-2017
  • Event Initiated Date
    2017-05-25
  • Event Date Posted
    2017-07-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155797
  • 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
    Prosthesis, tracheal, expandable - Product Code JCT
  • Reason
    Firm received a complaint that a customer who ordered an advanta v12 7mm x 22mm x 120cm received an advanta v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. the complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). the complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. this was the only complaint received for this non-conformance.
  • Action
    The firm, Getinge/Maquet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2017 via FedEx overnight to affected US consignees via FedEx Next Day Air. Getinge sent a second "URGENT MEDICAL DEVICE RECALL LETTER" dated June 2, 2017 via FedEx overnight to the affected customers in order to correct a product code/part number due to a typo in the initial letter and to assist in identifying the labeling problem. The letters described the product, problem and actions to be taken. Customers are instructed to examine your inventory; remove affected products; quarantine and place in a secure location; if you have the affected product, contact Getinge Customer Service at 1-603-880-1433, Monday through Friday between 9:00 am to 5:00 pm for RA and shipping instructions to return affected product to the Manufacturer, and complete and Return the enclosed Medical Device - Recall Response Form to email: catheterhub.us@getinge.com or fax to 1-973-807-9207. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.

Device

Device Recall iCAST and Advanta
  • Model / Serial
    Part Number 85455: Lots 240735, 240523;  Part Number 85355: Lot 240734
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
  • Product Description
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) || Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) || The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA