Devices › System, appendage closure, left atrial
Device brand name · Cardiac plug
Amplatzer Amulet: medical device reports filed with FDA
2,540 reports name it, 2022–2026. Manufacturer given most often on reports: Abbott Medical. Product code NGV.
- 2,540
- device reports naming the brand
- 0% of all MAUDE reports · about 565 a year
- 591
- reports, 12 months to August 2026
- 626 in the 12 months before
- 10.6%
- classified as malfunction
- 10.9% across the product code
- 12.3%
- classified as death, as reported
- 312 reports · not verified by FDA
2,540 medical device reports received by FDA name the brand "Amplatzer Amulet" (cardiac plug); the manufacturer given most often on reports is Abbott Medical; received from January 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
591 reports arrived in the 12 months to August 2026, close to the 626 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 (77.1%), death (12.3%) and malfunction (10.6%); across all system, appendage closure, left atrial reports (product code NGV) death is recorded in 10.6% and malfunction in 10.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (19.8%), patient device interaction problem (15.9%) and patient-device incompatibility (15.7%). The patient problems coded most often are pericardial effusion, cardiac tamponade and thrombosis/thrombus. 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 17,328 reports carrying product code NGV. 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 |
|---|---|---|---|
| Migration or expulsion of device | 503 | 19.8% | 3% |
| Patient device interaction problem | 405 | 15.9% | 2.4% |
| Patient-device incompatibilitythe device did not suit the patient | 398 | 15.7% | 2.3% |
| Improper or incorrect procedure or method | 115 | 4.5% | 0.7% |
| Difficult to fold, unfold or collapse | 37 | 1.5% | 0.3% |
| Premature separation | 37 | 1.5% | 0.4% |
| Insufficient device problem information | 36 | 1.4% | 0.3% |
| Material protrusion/extrusion | 20 | 0.8% | 0.1% |
| Contamination /decontamination problem | 18 | 0.7% | 0.1% |
| Fracturea broken bone | 13 | 0.5% | 0.1% |
| Air/gas in device | 12 | 0.5% | 0.2% |
| Malposition of device | 7 | 0.3% | 0.1% |
| Device difficult to setup or prepare | 5 | 0.2% | 0% |
| Separation problem | 5 | 0.2% | 0% |
| Difficult to advance | 4 | 0.2% | 0.1% |
| Material deformation | 4 | 0.2% | 2.7% |
| Off-label use | 4 | 0.2% | 0% |
| Fluid/blood leak | 2 | 0.1% | 0% |
| Migrationthe device moved from where it was placed | 2 | 0.1% | 4.4% |
| Detachment of device or device componentpart of the device came off | 1 | 0% | 1% |
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 |
|---|---|---|
| Pericardial effusionfluid around the heart | 1,016 | 40% |
| Cardiac tamponade | 427 | 16.8% |
| Thrombosis/thrombus | 337 | 13.3% |
| Low blood pressure/ hypotension | 178 | 7% |
| Angina | 174 | 6.9% |
| Hemorrhage/blood loss/bleeding | 156 | 6.1% |
| Stroke/cva | 147 | 5.8% |
| Cardiac arrestthe heart stopped | 128 | 5% |
| Dyspneashortness of breath | 107 | 4.2% |
| Perforation | 79 | 3.1% |
| Obstruction/occlusion | 58 | 2.3% |
| Pericarditisinflammation of the sac around the heart | 54 | 2.1% |
| Transient ischemic attack | 54 | 2.1% |
| Atrial fibrillationan irregular heart rhythm | 50 | 2% |
| Heart failure/congestive heart failure | 48 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Amplatzer Amulet | Product code NGV | All MAUDE reports |
|---|---|---|---|
| Reports | 2,540 | 17,328 | 26,136,888 |
| Share of that pool | — | 14.7% | 0% |
| Classified as death, per 1,000 reports | 123 | 106 | 9 |
| Classified as injury | 77.1% | 78.5% | 36.2% |
| Classified as malfunction | 10.6% | 10.9% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.1% | 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 NGV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| WATCHMAN LAA Closure Device & Delivery System | 4,042 | 35 | 9.2% |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System | 3,923 | 131 | 10.9% |
| WATCHMAN FLX? Pro | 2,416 | 1,386 | 12% |
| WATCHMAN Access System | 2,081 | 12 | 4.5% |
| Watchman Flx | 593 | 190 | 18% |
| WATCHMAN FLX Pro LAA Closure Device with Delivery System | 454 | 57 | 6.6% |
| Watchman Flx Laa Closure Device & Delivery System | 281 | 0 | 14.6% |
| WATCHMAN TruSeal Access System | 716 | 50 | 8% |
| WATCHMAN FXD Curve Access System | 973 | 198 | 9.6% |
| WATCHMAN TruSteer? Access System | 401 | 260 | 9.2% |
| Abbott | 265 | 0 | 7.5% |
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 Amplatzer Amulet reports
How many FDA reports name Amplatzer Amulet?
2,540 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 591 in the latest 12 months.
What kinds of events are reported?
injury (77.1%), death (12.3%) and malfunction (10.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (19.8%), patient device interaction problem (15.9%), patient-device incompatibility (15.7%), improper or incorrect procedure or method (4.5%) and difficult to fold, unfold or collapse (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Amplatzer Amulet 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.