Devices

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
1 Event
- Recall of Device Recall iCAST and Advanta

Manufacturer

Atrium Medical Corporation

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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