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FDA product code LTI · class 3 · Unknown
Implant, intragastric for morbid obesity: medical device reports filed with FDA
17,678 reports carry this product code, 1994–2026; 19 brands with a page.
- 17,678
- reports with this product code
- 0.1% of all MAUDE reports
- 204
- reports, 12 months to August 2026
- 334 in the 12 months before
- 60.3%
- classified as malfunction
- 62.3% across all reports
- 1.1%
- classified as death, as reported
- 0.9% across all reports
Product code LTI is FDA's classification for "Implant, intragastric for morbid obesity" (unknown panel), a class 3 device. 17,678 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1994 to August 2026.
204 reports arrived in the 12 months to August 2026, down 39% from 334 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 (60.3%), injury (38.1%) and death (1.1%). 19 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Allergan | 5,136 | 29.1% |
| Bioenterics | 3,298 | 18.7% |
| Apollo Endosurgery | 2,226 | 12.6% |
| Obtech Medical Sarl | 1,826 | 10.3% |
| Reshape Lifesciences | 1,121 | 6.3% |
| Allergan Costa Rica | 182 | 1% |
| Ethicon Endo-Surgery | 68 | 0.4% |
| Ethicon Endo Surgery | 7 | 0% |
| Boston Scientific Ireland | 1 | 0% |
| Cordis Europa | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Explanted | 5,242 | 29.7% |
| Leak/splashthe device leaked | 4,164 | 23.6% |
| Fluid/blood leak | 3,376 | 19.1% |
| Device slipped | 1,628 | 9.2% |
| Insufficient device problem information | 1,049 | 5.9% |
| Deflation problem | 942 | 5.3% |
| Breakthe device broke | 748 | 4.2% |
| Device remains implanted | 689 | 3.9% |
| Replace | 580 | 3.3% |
| Migration or expulsion of device | 532 | 3% |
| Patient-device incompatibilitythe device did not suit the patient | 426 | 2.4% |
| Material rupture | 425 | 2.4% |
| Port leak(s) | 390 | 2.2% |
| Component(s), broken | 373 | 2.1% |
| Disconnection | 364 | 2.1% |
| Inflation problem | 279 | 1.6% |
| Material erosion | 234 | 1.3% |
| Unintended deflation | 215 | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 166 | 0.9% |
| Air/gas in device | 165 | 0.9% |
Questions about implant, intragastric for morbid obesity reports
What is product code LTI?
FDA's classification code for "Implant, intragastric for morbid obesity", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
17,678 reports through August 2026, 204 of them in the latest 12 months.
Which brands appear most often?
Lap-Band Adjustable Gastric Banding System (2,174), Lap-Band Adjustable Gastric Banding System Unk Size (1,781), Lap-Band Adjustable Gastric Banding System 9 75cm (1,488), Lap-Band System (1,357) and Lap-Band Adjustable Gastric Banding System 10 0cm (1,184). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.