Transcatheter septal occluder: medical device reports filed with FDA

6,948 reports carry this product code, 1999–2026; 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.

6,948
reports with this product code: 0% of all MAUDE reports; 854
reports, 12 months to August 2026: 801 in the 12 months before; 37.8%
classified as malfunction: 62.3% across all reports; 2.8%
classified as death, as reported: 0.9% across all reports

Product code MLV is FDA's classification for "Transcatheter septal occluder" (unknown panel), a class 3 device. 6,948 medical device reports carry this product code, 0% of the MAUDE database, from October 1999 to August 2026.

854 reports arrived in the 12 months to August 2026, close to the 801 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 (58.1%), malfunction (37.8%) and death (2.8%). 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
Amplatzer Septal Occluder	3,490	406	2.4%	43.4%
Amplatzer PFO Occluder	596	42	2.8%	45.7%
GORE CARDIOFORM Septal Occluder	535	80	1.3%	6.2%
Amplatzer Talisman PFO Occluder	426	125	0.9%	67.8%
Gore Helex Septal Occluder	279	0	0.4%	5.4%
Amplatzer Cribriform Occluder	278	0	0.4%	37.3%
GORE CARDIOFORM ASD Occluder	274	57	0.7%	4.4%
Amplatzer Multi-Fenestrated Septal Occluder - Cribriform	255	63	0.4%	82%
Amplatzer Muscular VSD Occluder	242	44	9.1%	24.4%
Amplatzer Duct Occluder	17	83	2.1%	40.4%
Amplatzer Torqvue Delivery System	2	29	7.2%	42.8%
GORE DrySeal Flex Introducer Sheath	1	283	5.3%	8.6%

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
Abbott Medical	3,184	45.8%
Aga Medical	2,388	34.4%
W L Gore & Associates	1,093	15.7%
St Jude Medical Costa Rica Ltda	6	0.1%
Medtronic Vascular	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

Death2.8%198

Injury58.1%4,036

Malfunction37.8%2,628

Other0.4%30

Not given0.8%56

Who filed

Manufacturer report97.4%6,765

Voluntary report1.2%85

User facility report0%0

Distributor report0%1

Not given1.4%97

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

Device problems coded

Device problem (FDA code)	Reports	Share
Difficult to fold, unfold or collapse	1,841	26.5%
Migration or expulsion of device	1,005	14.5%
Material deformation	823	11.8%
Patient device interaction problem	346	5%
Explanted	279	4%
Insufficient device problem information	263	3.8%
Patient-device incompatibilitythe device did not suit the patient	192	2.8%
Device dislodged or dislocated	180	2.6%
Off-label use	167	2.4%
Unintended movement	161	2.3%
Inadequacy of device shape and/or size	158	2.3%
Migrationthe device moved from where it was placed	128	1.8%
Difficult to removethe device was hard to remove	114	1.6%
Device operates differently than expectedthe device behaved unexpectedly	107	1.5%
Device, removal of (non-implant)	106	1.5%
Improper or incorrect procedure or method	96	1.4%
Biocompatibility	95	1.4%
Replace	91	1.3%
Device remains implanted	81	1.2%
Malposition of device	79	1.1%

Questions about transcatheter septal occluder reports

What is product code MLV?

FDA's classification code for "Transcatheter septal occluder", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,948 reports through August 2026, 854 of them in the latest 12 months.

Which brands appear most often?

Amplatzer Septal Occluder (3,490), Amplatzer PFO Occluder (596), GORE CARDIOFORM Septal Occluder (535), Amplatzer Talisman PFO Occluder (426) and Gore Helex Septal Occluder (279). 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.