Atrium Medical Corporation: Medical Device Recall in 2017 - (Recall #: Z-2761-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 25, 2017

Date Posted: August 2, 2017

Recall Number: Z-2761-2017

Event ID: 77342

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.

Status: Terminated

Product Quantity: 246 (US: 183 units; Foreign: 63 units)

Code Information:

Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734

Distribution Pattern:

Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.

Voluntary or Mandated:

Voluntary: Firm initiated