ORBERA365 Intragastric Balloon System
Received Jul 27, 2026 · Event occurred Jun 26, 2026
Report 3005099803-2026-03014 · MDR key 50001099
Device
Generic name
Implant, Intragastric For Morbid Obesity
Manufacturer
Apollo EndosurgeryModel number
B-50012Catalog number
B-50012
Lot number
AF06476
Product problems
- Migration
Patient
Not reported
- Abdominal Pain
- Vomiting
- Obstruction/Occlusion
Narrative
Description of Event or Problem
It was reported to Boston Scientific Corporation that an Orbera365 balloon was utilized during an intragastric balloon implantation procedure on (b)(6) 2025.On (b)(6) 2026, the patient presented with vomiting and severe abdominal pain. A computed tomography (CT) scan demonstrated that the gastric balloon was obstructing the jejunum. A laparotomy was performed to remove the gastric balloon. The balloon was successfully removed, and the patient is reported to be recovering following surgery.
Additional Manufacturer Narrative
Block H6:IMDRF code A010402 captures the reportable event of Migration. IMDRF code F2203 captures the reportable event of Imaging Required.IMDRF code E2328 captures the reportable event of Obstruction / Occlusion.IMDRF code F19 captures the reportable event of Surgical Intervention. IMDRF code F2303: captures the reportable event of Medication Required.IMDRF code F08 captures the reportable event of Hospitalization or Prolonged Hospitalization.