NYTClass IIImplant
Prosthesis, Tracheal, Expandable, Polymeric
General, Plastic Surgery · 21 CFR 878.3720
The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.
MDR events55All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
55 adverse event reports on file
- DYNAMIC Y STENTMay 2, 2024InjuryBoston Scientific Corporation3005099803-2024-02005
- DYNAMIC Y STENTAug 15, 2019MalfunctionBoston Scientific Corporation3005099803-2019-03969
- POLYFLEX AIRWAY STENT SETSNov 30, 2017MalfunctionBoston Scientific - Galway3005099803-2017-03619
- POLYFLEX AIRWAY STENT SETSNov 30, 2017MalfunctionBoston Scientific - Galway3005099803-2017-03620
- POLYFLEX AIRWAY STENT SETSMay 24, 2017InjuryBoston Scientific - Galway3005099803-2017-01461
- DYNAMIC Y STENTApr 12, 2016InjuryWilly Ruesch Gmbh3005099803-2016-00962
- DYNAMIC Y STENTApr 12, 2016InjuryWilly Ruesch Gmbh3005099803-2016-00963
- DYNAMIC Y STENTMay 22, 2015MalfunctionWilly Ruesch Gmbh3005099803-2015-01445
- DYNAMIC Y STENTMar 12, 2015MalfunctionWilly Ruesch Gmbh3005099803-2015-00534
- DYNAMIC Y STENTJun 3, 2014InjuryWilly Ruesch Gmbh3005099803-2014-02144
Event type breakdown
Injury34
Malfunction13
Death8
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code