EvoEndo Model LE Single-Use GastroscopeRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850031897014), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Off-Label Use; Off-Label Use

  THE FOLLOWING EVENT DEPICTS AN OFF-LABEL USE OF THE EVOENDO SINGLE USE DISPOSABLE GASTROSCOPE. HISTORY: A 2 MONTH OLD, EX-25 WEEK, VERY-LOW BIRTH WEIGHT (730 G) PREMATURE MALE INFANT, WHO AT A CORRECTED GESTATIONAL AGE OF 33 WEEKS AND 2 KG (4.4 LB) REMAINED ADMITTED IN THE NEONATAL INTENSIVE CARE UNIT (NICU) SINCE BIRTH DUE TO HIS EXTREME PREMATURITY AND MEDICAL CONDITIONS. HE HAD MULTIPLE CONGENITAL BOWEL ANOMALIES AND WAS FED SOLELY BY TOTAL PARENTERAL NUTRITION. THESE INCLUDED DUODENAL ATRESIA (LACK OF EXIT DISTALLY FROM THE STOMACH TO THE DUODENUM/SMALL INTESTINE) AND LONG-GAP ESOPHAGEAL ATRESIA (LACK OF ENTRANCE TO THE STOMACH FROM THE MOUTH/ESOPHAGUS). AS A RESULT OF THIS ANOMALY THE STOMACH WAS ALSO SMALLER THAN EXPECTED FOR GESTATIONAL AGE. THE CHILD WAS FED COMPLETELY BY PARENTERAL NUTRITION. A SURGICAL GASTROSTOMY TUBE WAS PREVIOUSLY PLACED BY PEDIATRIC SURGERY SHORTLY AFTER BIRTH (2 MONTHS PRIOR) BUT WAS NOT USED FOR FEEDING DUE TO THE DUODENAL ATRESIA. PROCEDURE: THE CHILD WAS BROUGHT TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE DUODENAL ATRESIA FOR THE FIRST STAGE OF THE MULTI-STAGE REPAIR PROCESS RELATING TO THE BOWEL ANOMALIES. THE GASTROENTEROLOGY TEAM WISHED TO

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 22721194 ↗