Devices › Device, hemostasis, vascular
Device brand name · Vascular closure device
Manta 18f: medical device reports filed with FDA
853 reports name it, 2020–2026. Manufacturer given most often on reports: Essential Medical. Product code MGB.
- 853
- device reports naming the brand
- 0% of all MAUDE reports · about 140 a year
- 31
- reports, 12 months to August 2026
- 92 in the 12 months before
- 31.1%
- classified as malfunction
- 16.4% across the product code
- 1.4%
- classified as death, as reported
- 12 reports · not verified by FDA
853 medical device reports received by FDA name the brand "Manta 18f" (vascular closure device); the manufacturer given most often on reports is Essential Medical; received from June 2020 to January 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
31 reports arrived in the 12 months to August 2026, down 66% from 92 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 (67.5%), malfunction (31.1%) and death (1.4%); across all device, hemostasis, vascular reports (product code MGB) death is recorded in 0.6% and malfunction in 16.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are physical resistance/sticking (24.5%), malposition of device (17.9%) and misconnection (11.6%). The patient problems coded most often are obstruction/occlusion, extravasation and hemorrhage/blood loss/bleeding. 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 124,366 reports carrying product code MGB. 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 |
|---|---|---|---|
| Physical resistance/sticking | 209 | 24.5% | 0.7% |
| Malposition of device | 153 | 17.9% | 3% |
| Misconnection | 99 | 11.6% | 0.2% |
| Patient device interaction problem | 93 | 10.9% | 1.5% |
| Failure to seal | 38 | 4.5% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 33 | 3.9% | 0.1% |
| Difficult to advance | 31 | 3.6% | 0.6% |
| Insufficient device problem information | 29 | 3.4% | 3% |
| Obstruction of flow | 24 | 2.8% | 1.1% |
| Positioning problem | 22 | 2.6% | 0.2% |
| Activation, positioning or separation problem | 19 | 2.2% | 1.7% |
| Failure to advance | 14 | 1.6% | 0.9% |
| Material separation | 13 | 1.5% | 6.9% |
| Breakthe device broke | 7 | 0.8% | 1.5% |
| Positioning failure | 6 | 0.7% | 4.5% |
| Activation failure | 5 | 0.6% | 0.9% |
| Deformation due to compressive stress | 5 | 0.6% | 0.3% |
| Improper or incorrect procedure or method | 4 | 0.5% | 4.6% |
| Detachment of device or device componentpart of the device came off | 3 | 0.4% | 0.9% |
| Material split, cut or torn | 3 | 0.4% | 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 |
|---|---|---|
| Obstruction/occlusion | 213 | 25% |
| Extravasation | 138 | 16.2% |
| Hemorrhage/blood loss/bleeding | 135 | 15.8% |
| Vascular dissection | 91 | 10.7% |
| Hematomaa collection of blood under the skin or in tissue | 43 | 5% |
| Pseudoaneurysm | 34 | 4% |
| Retroperitoneal hemorrhage | 21 | 2.5% |
| Reduced blood flow | 13 | 1.5% |
| Stenosis | 11 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 9 | 1.1% |
| Low blood pressure/ hypotension | 7 | 0.8% |
| Painpain, site not specified | 7 | 0.8% |
| Perforation of vessels | 7 | 0.8% |
| Diminished pulse pressure | 6 | 0.7% |
| Thrombosis/thrombus | 6 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Manta 18f | Product code MGB | All MAUDE reports |
|---|---|---|---|
| Reports | 853 | 124,366 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 14 | 6 | 9 |
| Classified as injury | 67.5% | 82.5% | 36.2% |
| Classified as malfunction | 31.1% | 16.4% | 62.3% |
| Filed by the manufacturer | 100% | 97.5% | 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 MGB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Perclose Proglide 6f Suture Mediated Closure Smc System | 46,236 | 0 | 0.3% |
| Perclose ProStyle Suture-Mediated Closure and Repair System | 16,441 | 22 | 0% |
| Perclose ProStyle | 12,935 | 2,308 | 0.1% |
| Starclose Se Vascular Closure System | 6,432 | 0 | 0.4% |
| Perclose ProGlide | 3,554 | 653 | 0.9% |
| Angio-Seal | 2,523 | 902 | 0.8% |
| Exoseal | 2,441 | 1,161 | 0% |
| 6f Angio-Seal Vip Vascular Closure Device Ous | 1,818 | 0 | 0.3% |
| Mynx Control | 1,766 | 768 | 0.1% |
| Starclose Vascular Closure System | 1,880 | 8 | 1.2% |
| 6f Angio-Seal Vip Vascular Closure Device Us | 1,617 | 0 | 0.2% |
| Mynxgrip | 1,254 | 422 | 0.3% |
| Prostar Xl Suture-Mediated Closure | 1,239 | 0 | 3.1% |
| Mynxgrip Vascular Closure Device 6f-7f | 1,171 | 0 | 0.6% |
| 8f Angio-Seal Vip Vascular Closure Device Ous | 1,056 | 0 | 0.3% |
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 Manta 18f reports
How many FDA reports name Manta 18f?
853 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 31 in the latest 12 months.
What kinds of events are reported?
injury (67.5%), malfunction (31.1%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (24.5%), malposition of device (17.9%), misconnection (11.6%), patient device interaction problem (10.9%) and failure to seal (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Manta 18f 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.