Esophageal Dilator Balloon With Or Without Electrode Sensors
Boston Scientific Corporation's record for this product code
MDR events38All time
Recalls0All time
510(k) clearances0All time
Recent MDR events
38 adverse event reports on file
- RIGIFLEX IIJul 21, 2026Injury3005099803-2026-02977
- RIGIFLEX IIMar 17, 2026Injury3005099803-2026-00970
- RIGIFLEX IISep 29, 2025Malfunction3005099803-2025-04962
- RIGIFLEX IIMay 23, 2025Malfunction3005099803-2025-02302
- RIGIFLEX IIMay 12, 2025Malfunction3005099803-2025-02049
- RIGIFLEX IIMar 25, 2025Injury3005099803-2025-01215
- RIGIFLEX IIMar 25, 2025Death3005099803-2025-01243
- RIGIFLEX IIMar 24, 2025Injury3005099803-2025-01212
- RIGIFLEX IIJan 24, 2025Malfunction3005099803-2025-00155
- RIGIFLEX IIJan 10, 2025Malfunction3005099803-2024-06844
Recalls
0 recall events for this product code
No recalls on file for Boston Scientific Corporation under this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Boston Scientific Corporation under this product code.