Implant, anti-gastroesophageal reflux: medical device reports filed with FDA

2,244 reports carry this product code, 1992–2026; 8 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,244
reports with this product code: 0% of all MAUDE reports; 140
reports, 12 months to August 2026: 174 in the 12 months before; 4.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code LEI is FDA's classification for "Implant, anti-gastroesophageal reflux" (unknown panel), a class 3 device. 2,244 medical device reports carry this product code, 0% of the MAUDE database, from October 1992 to August 2026.

140 reports arrived in the 12 months to August 2026, down 20% from 174 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 injury (94.5%), malfunction (4.6%) and other (0.8%). 8 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Linx Reflux Management System	483	0	0%	1%
Unk Linx Magnetic Implant	396	13	0.3%	3.8%
1 5t Linx 14b	286	19	0%	5.2%
1 5t Linx 15b	273	14	0%	4.8%
Linx 1 5 16 Bead Us	183	6	0.5%	5.5%
1 5t Linx 13b	157	9	0%	2.5%
Lap-Band Adjustable Gastric Banding System	2	0	2%	69.3%
Lap-Band Adjustable Gastric Banding System 9 75cm	2	0	0.1%	84.8%

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
Torax Medical	2,212	98.6%
Mentor	6	0.3%
Bioenterics	5	0.2%
Mentor Texas	2	0.1%
American Heyer-Schulte	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

Death0.1%2

Injury94.5%2,120

Malfunction4.6%103

Other0.8%18

Not given0%1

Who filed

Manufacturer report98.4%2,208

Voluntary report1.1%25

User facility report0%0

Distributor report0%0

Not given0.5%11

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device appears to trigger rejection	685	30.5%
Patient device interaction problem	456	20.3%
Detachment of device or device componentpart of the device came off	311	13.9%
Migration or expulsion of device	197	8.8%
Insufficient device problem information	94	4.2%
Therapeutic or diagnostic output failure	42	1.9%
Unexpected therapeutic results	21	0.9%
Device-device incompatibility	19	0.8%
Material erosion	19	0.8%
Patient-device incompatibilitythe device did not suit the patient	18	0.8%
Nonstandard device	13	0.6%
Defective component	9	0.4%
Explanted	9	0.4%
Breakthe device broke	7	0.3%
Material separation	7	0.3%
Device operates differently than expectedthe device behaved unexpectedly	6	0.3%
Improper or incorrect procedure or method	5	0.2%
Malposition of device	5	0.2%
Component(s), broken	4	0.2%
Disconnection	4	0.2%

Questions about implant, anti-gastroesophageal reflux reports

What is product code LEI?

FDA's classification code for "Implant, anti-gastroesophageal reflux", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,244 reports through August 2026, 140 of them in the latest 12 months.

Which brands appear most often?

Linx Reflux Management System (483), Unk Linx Magnetic Implant (396), 1 5t Linx 14b (286), 1 5t Linx 15b (273) and Linx 1 5 16 Bead Us (183). 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.