MalfunctionFGE
CRE PRO
Received Jul 21, 2026 · Event occurred Jun 30, 2026
Report 3005099803-2026-02985 · MDR key 25896882
Device
Generic name
Balloon Dilator
Manufacturer
Boston Scientific CorporationModel number
M00558640Catalog number
M00558640
Lot number
0036775365
Product problems
- Material Split, Cut or Torn
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions