Devices › Implant, intragastric for morbid obesity
Device brand name · Intragastric balloon system
ORBERA365 Intragastric Balloon System: medical device reports filed with FDA
350 reports name it, 2019–2026. Manufacturer given most often on reports: Apollo Endosurgery. Product code LTI.
- 350
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 29
- reports, 12 months to August 2026
- 34 in the 12 months before
- 77.4%
- classified as malfunction
- 60.3% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
350 medical device reports received by FDA name the brand "ORBERA365 Intragastric Balloon System" (intragastric balloon system); the manufacturer given most often on reports is Apollo Endosurgery; received from April 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
29 reports arrived in the 12 months to August 2026, down 15% from 34 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (77.4%), injury (22.3%) and death (0.3%); across all implant, intragastric for morbid obesity reports (product code LTI) death is recorded in 1.1% and malfunction in 60.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are deflation problem (49.7%), fluid/blood leak (40.3%) and unintended deflation (30%). The patient problems coded most often are failure of implant, vomiting and abdominal pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 17,678 reports carrying product code LTI. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Deflation problem | 174 | 49.7% | 5.3% |
| Fluid/blood leak | 141 | 40.3% | 19.1% |
| Unintended deflation | 105 | 30% | 1.2% |
| Migrationthe device moved from where it was placed | 36 | 10.3% | 0.6% |
| Inflation problem | 33 | 9.4% | 1.6% |
| Patient-device incompatibilitythe device did not suit the patient | 12 | 3.4% | 2.4% |
| Leak/splashthe device leaked | 9 | 2.6% | 23.6% |
| Migration or expulsion of device | 9 | 2.6% | 3% |
| Detachment of device or device componentpart of the device came off | 6 | 1.7% | 0.4% |
| Burst container or vessel | 5 | 1.4% | 0% |
| Difficult to removethe device was hard to remove | 5 | 1.4% | 0.3% |
| Insufficient device problem information | 5 | 1.4% | 5.9% |
| Material split, cut or torn | 5 | 1.4% | 0.1% |
| Material separation | 4 | 1.1% | 0.4% |
| Mechanical problema mechanical problem | 3 | 0.9% | 0.1% |
| Contamination | 2 | 0.6% | 0% |
| Deformation due to compressive stress | 2 | 0.6% | 0.1% |
| Failure to advance | 2 | 0.6% | 0% |
| Failure to deflate | 2 | 0.6% | 0% |
| Increase in pressure | 2 | 0.6% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Failure of implant | 165 | 47.1% |
| Vomitingbeing sick | 69 | 19.7% |
| Abdominal painstomach or belly pain | 39 | 11.1% |
| Nauseafeeling sick | 20 | 5.7% |
| Obstruction/occlusion | 20 | 5.7% |
| Painpain, site not specified | 15 | 4.3% |
| Discomfortdiscomfort | 11 | 3.1% |
| Dehydrationdehydration | 9 | 2.6% |
| Perforation | 7 | 2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 6 | 1.7% |
| Heartburn/indigestion | 5 | 1.4% |
| Hemorrhage/blood loss/bleeding | 4 | 1.1% |
| Airway obstruction | 3 | 0.9% |
| Inflammationinflammation | 3 | 0.9% |
| Internal organ perforation | 3 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ORBERA365 Intragastric Balloon System | Product code LTI | All MAUDE reports |
|---|---|---|---|
| Reports | 350 | 17,678 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 3 | 11 | 9 |
| Classified as injury | 22.3% | 38.1% | 36.2% |
| Classified as malfunction | 77.4% | 60.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LTI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Lap-Band Adjustable Gastric Banding System | 2,199 | 0 | 2% |
| Lap-Band Adjustable Gastric Banding System Unk Size | 1,781 | 0 | 2% |
| Lap-Band Adjustable Gastric Banding System 9 75cm | 1,513 | 0 | 0.1% |
| Lap-Band System | 1,357 | 0 | 2% |
| Lap-Band Adjustable Gastric Banding System 10 0cm | 1,187 | 0 | 0.4% |
| Spatz3 Adjustable Balloon System | 906 | 125 | 0.6% |
| Orbera Intragastric Balloon System | 828 | 10 | 2.5% |
| Lap-Band Ap Adjustable Gastric Banding System Standard | 801 | 0 | 0.4% |
| Realize Adj Gastric Band Str | 527 | 0 | 0.2% |
| Realize Adj Gastric Band-C | 524 | 0 | 0% |
| Lap-Band Adjustable Gastric Banding System Vg | 493 | 0 | 0.8% |
| Lap-Band Ap Adjustable Gastric Banding System Small | 448 | 0 | 1.1% |
| Lap-Band Ap Adjustable Gastric Banding System Large | 437 | 0 | 1.1% |
| Sagb Quickclose With Velocity Injection Port | 245 | 0 | 0% |
| Gen2 Adjustable Gastric Band - 11 Cm Unlocka | 196 | 0 | 0.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about ORBERA365 Intragastric Balloon System reports
How many FDA reports name ORBERA365 Intragastric Balloon System?
350 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 29 in the latest 12 months.
What kinds of events are reported?
malfunction (77.4%), injury (22.3%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
deflation problem (49.7%), fluid/blood leak (40.3%), unintended deflation (30%), migration (10.3%) and inflation problem (9.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ORBERA365 Intragastric Balloon System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.