MalfunctionFGE
CRE PRO
Received Jul 16, 2026 · Event occurred Jun 1, 2026
Report 3005099803-2026-02897 · MDR key 25850510
Device
Generic name
Balloon Dilator
Manufacturer
Boston Scientific CorporationModel number
M00558660Catalog number
M00558660
Lot number
0037597734
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions