inforMED
MalfunctionGCA

FUSION QUATTRO EXTRACTION BALLOON

Received Jul 16, 2026

Report 1037905-2026-00353 · MDR key 25850036

Device

Generic name

D2a Common Device Name: Biliary Catheter For Stone Removal That May Also Allow F

Model number

G48225

Catalog number

FS-QEB-A

Lot number

W4970175

Product problems

  • Material Rupture

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions