Class 2 Device Recall iCAST and Advanta

• Date Initiated by Firm: May 25, 2017
• Date Posted: July 07, 2017
• Recall Status: Terminated on June 26, 2020
• Recall Number: Z-2761-2017
• Recall Event ID: 77342
• 510(K)Number: K050814
• Product Classification: Prosthesis, tracheal, expandable - Product Code JCT
• Product: 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.
• Code Information: Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 5 Wentworth Dr; Hudson NH 03051-4929
• For Additional Information Contact: Karen LeFevere; 973-709-7652
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• 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.
• Quantity in Commerce: 246 (US: 183 units; Foreign: 63 units)
• Distribution: Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JCT