Ascendo 00712934Recalls & reported problems
US Endoscopy · Ascendo Submucosal Lifting Agent · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995221614), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT A PATIENT RECEIVED A "BURN" ON THEIR ASCENDING COLON AFTER BEING INJECTED WITH ASCENDO SUBMUCOSAL LIFTING AGENT. IT IS UNKNOWN IF ADDITIONAL MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Burn(s)
MAUDE report 20820222 ↗
Other Submucosal injection agent devices
- ORISE™ Gel M00519220Boston Scientific Corporation · Submucosal injection agent1 recall2 reports
- ORISE™ Gel M00519200Boston Scientific Corporation · Submucosal injection agent1 recall1 report
- ORISE™ Gel M00519230Boston Scientific Corporation · Submucosal injection agent1 recall0 reports
- ORISE™ Gel M00519210Boston Scientific Corporation · Submucosal injection agent1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.