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.
Enforcement
- Recall Number
- Z-2761-2017
- Event ID
- 77342
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Atrium Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 2, 2017
- Initiation Date
- May 25, 2017
- Classification Date
- July 25, 2017
- Termination Date
- June 26, 2020
- Address
- 5 Wentworth Dr, N/A, Hudson, NH, 03051-4929, United States
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.
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.
Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734
Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
246 (US: 183 units; Foreign: 63 units)