UROMAX ULTRA
Received Jul 9, 2026 · Event occurred Jun 1, 2026
Report 2124215-2026-36659 · MDR key 25773147
Device
Generic name
Dilator, Catheter, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0062251070Catalog number
M0062251070
Lot number
0033187173
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED IN A PROCEDURE. REPORTEDLY, AFTER OPENING AND TRIED TO USE WITH CONTRAST, A LEAKING WAS NOTICED THROUGH THE CARACK ON THE SIDE OF THE TUBE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Additional Manufacturer Narrative
BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO 06/01/2026 BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: DEVICE CODE A050401 CAPTURES THE REPORTABLE EVENT OF BALLOON LEAK.