MalfunctionFGE
EZDILATE BALLOON DILATOR (WG) 13.5-14.5-15.5
Received Jul 7, 2026 · Event occurred Jun 16, 2026
Report 3011050570-2026-00709 · MDR key 25742309
Device
Generic name
Ezdilate Balloon Dilator (wg) 13.5-14.5-15.5
Manufacturer
Gyrus Acmi, Inc.Model number
BD-410X-1555Lot number
520707
Product problems
- Deflation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED DURING A THERAPEUTIC DILATION PROCEDURE, WHILE THE DEVICE WAS IN THE PATIENT AND THE PATIENT WAS UNDER SEDATION, THE BALLOON DILATOR DID NOT FULLY DEFLATE. NO PATIENT HARM WAS REPORTED.