Reported Reactions

Devices › Implant, intragastric for morbid obesity

Device brand name · Device for treatment of morbid obesity

Lap-Band Adjustable Gastric Banding System Vg: medical device reports filed with FDA

493 reports name it, 2004–2014. Manufacturer given most often on reports: Costa Rica. Product code LTI.

493
device reports naming the brand
0% of all MAUDE reports · about 22 a year
0
reports, 12 months to August 2026
0 in the 12 months before
68.4%
classified as malfunction
60.3% across the product code
0.8%
classified as death, as reported
4 reports · not verified by FDA

493 medical device reports received by FDA name the brand "Lap-Band Adjustable Gastric Banding System Vg" (device for treatment of morbid obesity); the manufacturer given most often on reports is Costa Rica; received from June 2004 to June 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (68.4%), injury (30.8%) and death (0.8%); 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 explanted (52.9%), leak/splash (47.1%) and fluid/blood leak (20.5%). The patient problems coded most often are surgical procedure, failure of implant and surgical procedure, repeated. 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

No report naming Lap-Band Adjustable Gastric Banding System Vg was received in the five years to August 2026; the latest was received in June 2014.

By year received

047942004: 1620042005: 322006: 4720062007: 622008: 9420082009: 632010: 5820102011: 522012: 4620122013: 182014: 52014

Event type and report source

Event type, as classified on the report

Death0.8%4
Injury30.8%152
Malfunction68.4%337
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%493
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Explanted26152.9%29.7%
Leak/splashthe device leaked23247.1%23.6%
Fluid/blood leak10120.5%19.1%
Device slipped397.9%9.2%
Device remains implanted377.5%3.9%
Port leak(s)163.2%2.2%
Breakthe device broke153%4.2%
Replace122.4%3.3%
Patient-device incompatibilitythe device did not suit the patient71.4%2.4%
Displacement40.8%0.4%
Inflation problem40.8%1.6%
Defective devicethe device was defective30.6%0.7%
Material erosion30.6%1.3%
Reflux within device30.6%0.2%
Deflation problem20.4%5.3%
Deformation due to compressive stress20.4%0.1%
Detachment of device component20.4%0.9%
Disconnection20.4%2.1%
Implant, removal of20.4%0.1%
Kinkedthe tube or line kinked20.4%0.4%

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)ReportsShare
Surgical procedure19038.5%
Failure of implant10521.3%
Surgical procedure, repeated8517.2%
Erosion244.9%
Vomitingbeing sick142.8%
Dysphagia/ odynophagia122.4%
Abdominal painstomach or belly pain112.2%
Hernia102%
Regurgitation102%
Painpain, site not specified91.8%
Heartburn/indigestion71.4%
Weight changes71.4%
Therapy/non-surgical treatment, additional61.2%
Obstruction/occlusion51%
Surgical procedure, additional51%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureLap-Band Adjustable Gastric Banding System VgProduct code LTIAll MAUDE reports
Reports49317,67826,136,888
Share of that pool—2.8%0%
Classified as death, per 1,000 reports8119
Classified as injury30.8%38.1%36.2%
Classified as malfunction68.4%60.3%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Lap-Band Adjustable Gastric Banding System2,19902%
Lap-Band Adjustable Gastric Banding System Unk Size1,78102%
Lap-Band Adjustable Gastric Banding System 9 75cm1,51300.1%
Lap-Band System1,35702%
Lap-Band Adjustable Gastric Banding System 10 0cm1,18700.4%
Spatz3 Adjustable Balloon System9061250.6%
Orbera Intragastric Balloon System828102.5%
Lap-Band Ap Adjustable Gastric Banding System Standard80100.4%
Realize Adj Gastric Band Str52700.2%
Realize Adj Gastric Band-C52400%
Lap-Band Ap Adjustable Gastric Banding System Small44801.1%
Lap-Band Ap Adjustable Gastric Banding System Large43701.1%
ORBERA365 Intragastric Balloon System350290.3%
Sagb Quickclose With Velocity Injection Port24500%
Gen2 Adjustable Gastric Band - 11 Cm Unlocka19600.5%

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 Lap-Band Adjustable Gastric Banding System Vg reports

How many FDA reports name Lap-Band Adjustable Gastric Banding System Vg?

493 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (68.4%), injury (30.8%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

explanted (52.9%), leak/splash (47.1%), fluid/blood leak (20.5%), device slipped (7.9%) and device remains implanted (7.5%). 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 Lap-Band Adjustable Gastric Banding System Vg 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.