System, appendage closure, left atrial: medical device reports filed with FDA

17,328 reports carry this product code, 2009–2026; 12 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.

17,328
reports with this product code: 0.1% of all MAUDE reports; 2,594
reports, 12 months to August 2026: 2,698 in the 12 months before; 10.9%
classified as malfunction: 62.3% across all reports; 10.6%
classified as death, as reported: 0.9% across all reports

Product code NGV is FDA's classification for "System, appendage closure, left atrial" (unknown panel), a class 3 device. 17,328 medical device reports carry this product code, 0.1% of the MAUDE database, from June 2009 to August 2026.

2,594 reports arrived in the 12 months to August 2026, close to the 2,698 of 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 (78.5%), malfunction (10.9%) and death (10.6%). 12 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
WATCHMAN LAA Closure Device & Delivery System	4,042	35	9.2%	13.5%
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System	3,922	131	10.9%	4.5%
Amplatzer Amulet	2,540	591	12.3%	10.6%
WATCHMAN FLX? Pro	2,415	1,386	12%	2.4%
WATCHMAN Access System	2,081	12	4.5%	36.6%
Watchman Flx	593	190	18%	0.7%
WATCHMAN FLX Pro LAA Closure Device with Delivery System	453	57	6.6%	2.4%
Watchman Flx Laa Closure Device & Delivery System	281	0	14.6%	2.1%
WATCHMAN TruSeal Access System	226	50	8%	24.9%
WATCHMAN FXD Curve Access System	185	198	9.6%	7%
WATCHMAN TruSteer? Access System	26	260	9.2%	7.5%
Abbott	1	0	7.5%	52.1%

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
Boston Scientific	9,038	52.2%
Abbott Medical	2,288	13.2%
Boston Scientific - Maple Grove	1,523	8.8%
Boston Scientific - Galway	1,016	5.9%
St Jude Medical Costa Rica Ltda	3	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

Death10.6%1,832

Injury78.5%13,606

Malfunction10.9%1,886

Other0%4

Not given0%0

Who filed

Manufacturer report99.1%17,176

Voluntary report0.7%118

User facility report0%0

Distributor report0%0

Not given0.2%34

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

Device problems coded

Device problem (FDA code)	Reports	Share
Migrationthe device moved from where it was placed	754	4.4%
Difficult to open or close	736	4.2%
Device dislodged or dislocated	667	3.8%
Migration or expulsion of device	522	3%
Difficult to removethe device was hard to remove	489	2.8%
Material deformation	472	2.7%
Failure to seal	431	2.5%
Patient device interaction problem	418	2.4%
Patient-device incompatibilitythe device did not suit the patient	403	2.3%
Material integrity problema problem with the device material	274	1.6%
Detachment of device or device componentpart of the device came off	174	1%
Leak/splashthe device leaked	157	0.9%
Kinkedthe tube or line kinked	143	0.8%
Improper or incorrect procedure or method	119	0.7%
Premature separation	71	0.4%
Insufficient device problem information	58	0.3%
Difficult to fold, unfold or collapse	49	0.3%
Gas/air leak	49	0.3%
Air leak	43	0.2%
Torn material	41	0.2%

Questions about system, appendage closure, left atrial reports

What is product code NGV?

FDA's classification code for "System, appendage closure, left atrial", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

17,328 reports through August 2026, 2,594 of them in the latest 12 months.

Which brands appear most often?

WATCHMAN LAA Closure Device & Delivery System (4,042), WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (3,922), Amplatzer Amulet (2,540), WATCHMAN FLX? Pro (2,415) and WATCHMAN Access System (2,081). 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.