Z-2761-2017Class II

Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S...

Name: Z-2761-2017 Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S...
Creator: Atrium Medical Corporation
Published: 2017-05-25
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2017-05-25 / Terminated / root cause: packaging

FDA source

Atrium Medical Corporation began a recall of 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... on 2017-05-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2761-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-07-07
Terminated: 2020-06-26
Recalling firm: Atrium Medical Corporation
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.
Product code: JCT Prosthesis, Tracheal, Expandable
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.
Root cause tag: packaging
FDA root 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: [email protected] 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.
Product codes and lots: Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2761-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2761-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-02	2017-07-25

Product code JCT

K050814Class IIAtrium Icast Covered StentAtrium Medical Corp. / cleared 2005-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)