Devices › System, appendage closure, left atrial
Device brand name · System appendage closure left atrial
WATCHMAN FLX? Pro: medical device reports filed with FDA
2,416 reports name it, 2024–2026. Manufacturer given most often on reports: Boston Scientific. Product code NGV.
- 2,416
- device reports naming the brand
- 0% of all MAUDE reports · about 1,117 a year
- 1,386
- reports, 12 months to August 2026
- 1,023 in the 12 months before
- 2.4%
- classified as malfunction
- 10.9% across the product code
- 12%
- classified as death, as reported
- 290 reports · not verified by FDA
FDA's MAUDE database holds 2,416 reports that name the brand "WATCHMAN FLX? Pro" (system appendage closure left atrial), received between May 2024 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
1,386 reports arrived in the 12 months to August 2026, up 35% from 1,023 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 (85.6%), death (12%) and malfunction (2.4%); 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 (11.4%), failure to seal (10.3%) and device dislodged or dislocated (5.4%). The patient problems coded most often are pericardial effusion, thrombosis/thrombus and low blood pressure/ hypotension. 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 276 | 11.4% | 4.4% |
| Failure to seal | 249 | 10.3% | 2.5% |
| Device dislodged or dislocated | 131 | 5.4% | 3.8% |
| Difficult to open or close | 57 | 2.4% | 4.2% |
| Premature separation | 30 | 1.2% | 0.4% |
| Detachment of device or device componentpart of the device came off | 25 | 1% | 1% |
| Material deformation | 25 | 1% | 2.7% |
| Material integrity problema problem with the device material | 21 | 0.9% | 1.6% |
| Activation failure | 17 | 0.7% | 0.2% |
| Nonstandard device | 17 | 0.7% | 0.2% |
| Difficult to removethe device was hard to remove | 13 | 0.5% | 2.8% |
| Difficult or delayed separation | 5 | 0.2% | 0% |
| Deformation due to compressive stress | 4 | 0.2% | 0.1% |
| Device contamination with chemical or other material | 3 | 0.1% | 0.1% |
| Device-device incompatibility | 2 | 0.1% | 0.1% |
| Difficult or delayed positioning | 2 | 0.1% | 0.1% |
| Positioning problem | 2 | 0.1% | 0.2% |
| Separation failure | 2 | 0.1% | 0% |
| Air/gas in device | 1 | 0% | 0.2% |
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 | 550 | 22.8% |
| Thrombosis/thrombus | 505 | 20.9% |
| Low blood pressure/ hypotension | 254 | 10.5% |
| Cardiac tamponade | 246 | 10.2% |
| Stroke/cva | 198 | 8.2% |
| Cardiac perforation | 167 | 6.9% |
| Chest painchest pain | 85 | 3.5% |
| Cardiac arrestthe heart stopped | 83 | 3.4% |
| Air embolism | 58 | 2.4% |
| Transient ischemic attack | 57 | 2.4% |
| Non specific ekg/ECG changes | 54 | 2.2% |
| Pericarditisinflammation of the sac around the heart | 45 | 1.9% |
| Dyspneashortness of breath | 42 | 1.7% |
| Muscle weakness/atrophy | 40 | 1.7% |
| Hemorrhage/blood loss/bleeding | 30 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WATCHMAN FLX? Pro | Product code NGV | All MAUDE reports |
|---|---|---|---|
| Reports | 2,416 | 17,328 | 26,136,888 |
| Share of that pool | — | 13.9% | 0% |
| Classified as death, per 1,000 reports | 120 | 106 | 9 |
| Classified as injury | 85.6% | 78.5% | 36.2% |
| Classified as malfunction | 2.4% | 10.9% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| Amplatzer Amulet | 2,540 | 591 | 12.3% |
| 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 WATCHMAN FLX? Pro reports
How many FDA reports name WATCHMAN FLX? Pro?
2,416 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,386 in the latest 12 months.
What kinds of events are reported?
injury (85.6%), death (12%) and malfunction (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (11.4%), failure to seal (10.3%), device dislodged or dislocated (5.4%), difficult to open or close (2.4%) and premature separation (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that WATCHMAN FLX? Pro 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.