Devices › Transcatheter septal occluder
Device brand name · Transcatheter septal occluder
Amplatzer Septal Occluder: medical device reports filed with FDA
3,495 reports name it, 2002–2026. Manufacturer given most often on reports: Abbott Medical. Product code MLV.
- 3,495
- device reports naming the brand
- 0% of all MAUDE reports · about 143 a year
- 406
- reports, 12 months to August 2026
- 409 in the 12 months before
- 43.4%
- classified as malfunction
- 37.8% across the product code
- 2.4%
- classified as death, as reported
- 83 reports · not verified by FDA
FDA's MAUDE database holds 3,495 reports that name the brand "Amplatzer Septal Occluder" (transcatheter septal occluder), received between February 2002 and August 2026; the manufacturer given most often on reports is Abbott Medical. Spellings of one product vary from report to report.
406 reports arrived in the 12 months to August 2026, close to the 409 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 (53%), malfunction (43.4%) and death (2.4%); across all transcatheter septal occluder reports (product code MLV) death is recorded in 2.8% and malfunction in 37.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to fold, unfold or collapse (33.3%), migration or expulsion of device (17.8%) and material deformation (13.4%). The patient problems coded most often are embolism, surgical procedure and pericardial effusion. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,948 reports carrying product code MLV. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Difficult to fold, unfold or collapse | 1,165 | 33.3% | 26.5% |
| Migration or expulsion of device | 623 | 17.8% | 14.5% |
| Material deformation | 468 | 13.4% | 11.8% |
| Explanted | 174 | 5% | 4% |
| Insufficient device problem information | 158 | 4.5% | 3.8% |
| Unintended movement | 122 | 3.5% | 2.3% |
| Inadequacy of device shape and/or size | 102 | 2.9% | 2.3% |
| Patient device interaction problem | 96 | 2.7% | 5% |
| Patient-device incompatibilitythe device did not suit the patient | 87 | 2.5% | 2.8% |
| Device dislodged or dislocated | 82 | 2.3% | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 57 | 1.6% | 1.5% |
| Device, removal of (non-implant) | 56 | 1.6% | 1.5% |
| Off-label use | 53 | 1.5% | 2.4% |
| Difficult to removethe device was hard to remove | 48 | 1.4% | 1.6% |
| Improper or incorrect procedure or method | 46 | 1.3% | 1.4% |
| Biocompatibility | 41 | 1.2% | 1.4% |
| Replace | 40 | 1.1% | 1.3% |
| Device remains implanted | 37 | 1.1% | 1.2% |
| Detachment of device component | 27 | 0.8% | 0.9% |
| Difficult to position | 27 | 0.8% | 0.7% |
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) | Reports | Share |
|---|---|---|
| Embolism | 225 | 6.4% |
| Surgical procedure | 187 | 5.4% |
| Pericardial effusionfluid around the heart | 149 | 4.3% |
| Cardiac tamponade | 123 | 3.5% |
| Therapy/non-surgical treatment, additional | 119 | 3.4% |
| Erosion | 117 | 3.3% |
| Chest painchest pain | 102 | 2.9% |
| Arrhythmia | 89 | 2.5% |
| Surgical procedure, additional | 75 | 2.1% |
| Foreign body, removal of | 69 | 2% |
| Atrial fibrillationan irregular heart rhythm | 61 | 1.7% |
| Low blood pressure/ hypotension | 60 | 1.7% |
| Hemorrhage/blood loss/bleeding | 54 | 1.5% |
| Deaththe patient died; cause not stated by this term | 48 | 1.4% |
| Treatment with medication(s) | 44 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Amplatzer Septal Occluder | Product code MLV | All MAUDE reports |
|---|---|---|---|
| Reports | 3,495 | 6,948 | 26,136,888 |
| Share of that pool | — | 50.3% | 0% |
| Classified as death, per 1,000 reports | 24 | 28 | 9 |
| Classified as injury | 53% | 58.1% | 36.2% |
| Classified as malfunction | 43.4% | 37.8% | 62.3% |
| Filed by the manufacturer | 99.3% | 97.4% | 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 MLV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Amplatzer PFO Occluder | 598 | 42 | 2.8% |
| GORE CARDIOFORM Septal Occluder | 535 | 80 | 1.3% |
| Amplatzer Talisman PFO Occluder | 426 | 125 | 0.9% |
| Gore Helex Septal Occluder | 279 | 0 | 0.4% |
| Amplatzer Cribriform Occluder | 279 | 0 | 0.4% |
| GORE CARDIOFORM ASD Occluder | 274 | 57 | 0.7% |
| Amplatzer Multi-Fenestrated Septal Occluder - Cribriform | 255 | 63 | 0.4% |
| Amplatzer Muscular VSD Occluder | 242 | 44 | 9.1% |
| Amplatzer Duct Occluder | 513 | 83 | 2.1% |
| Amplatzer Torqvue Delivery System | 208 | 29 | 7.2% |
| GORE DrySeal Flex Introducer Sheath | 1,177 | 283 | 5.3% |
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 Amplatzer Septal Occluder reports
How many FDA reports name Amplatzer Septal Occluder?
3,495 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 406 in the latest 12 months.
What kinds of events are reported?
injury (53%), malfunction (43.4%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to fold, unfold or collapse (33.3%), migration or expulsion of device (17.8%), material deformation (13.4%), explanted (5%) and insufficient device problem information (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Amplatzer Septal Occluder 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.