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FDA product code MGB · class 3 · Unknown
Device, hemostasis, vascular: medical device reports filed with FDA
124,366 reports carry this product code, 1996–2026; 30 brands with a page.
- 124,366
- reports with this product code
- 0.5% of all MAUDE reports
- 7,087
- reports, 12 months to August 2026
- 14,237 in the 12 months before
- 16.4%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 0.9% across all reports
Product code MGB is FDA's classification for "Device, hemostasis, vascular" (unknown panel), a class 3 device. 124,366 medical device reports carry this product code, 0.5% of the MAUDE database, from January 1996 to August 2026.
7,087 reports arrived in the 12 months to August 2026, down 50% from 14,237 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 (82.5%), malfunction (16.4%) and death (0.6%). 30 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
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 Vascular | 55,330 | 44.5% |
| Av-Temecula-Ct | 28,401 | 22.8% |
| Terumo Medical | 8,762 | 7% |
| Cordis US | 3,538 | 2.8% |
| Cordis Santa Clara | 2,802 | 2.3% |
| Abbott Vascular - Redwood City | 2,782 | 2.2% |
| Accessclosure | 2,496 | 2% |
| St Jude Medical | 2,303 | 1.9% |
| Abbott Vascular Redwood City | 2,122 | 1.7% |
| Perclose | 1,841 | 1.5% |
| Essential Medical | 1,616 | 1.3% |
| Cardinal Health Santa Clara | 1,546 | 1.2% |
| Cardinal Health | 1,136 | 0.9% |
| St Jude Medical Puerto Rico | 1,111 | 0.9% |
| Cordis | 992 | 0.8% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to cycle | 35,325 | 28.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 16,883 | 13.6% |
| Material separation | 8,567 | 6.9% |
| Improper or incorrect procedure or method | 5,738 | 4.6% |
| Positioning failure | 5,623 | 4.5% |
| Difficult to removethe device was hard to remove | 5,280 | 4.2% |
| Detachment of device component | 4,210 | 3.4% |
| Malposition of device | 3,729 | 3% |
| Insufficient device problem information | 3,682 | 3% |
| Difficult to insertthe device was hard to insert | 2,742 | 2.2% |
| Activation, positioning or separation problem | 2,114 | 1.7% |
| Difficult to open or close | 2,006 | 1.6% |
| Entrapment of device | 1,968 | 1.6% |
| Patient device interaction problem | 1,876 | 1.5% |
| Off-label use | 1,870 | 1.5% |
| Breakthe device broke | 1,844 | 1.5% |
| Defective component | 1,793 | 1.4% |
| Retraction problem | 1,614 | 1.3% |
| Mechanical jam | 1,579 | 1.3% |
| Material rupture | 1,567 | 1.3% |
Questions about device, hemostasis, vascular reports
What is product code MGB?
FDA's classification code for "Device, hemostasis, vascular", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
124,366 reports through August 2026, 7,087 of them in the latest 12 months.
Which brands appear most often?
Perclose Proglide 6f Suture Mediated Closure Smc System (46,235), Perclose ProStyle Suture-Mediated Closure and Repair System (16,441), Perclose ProStyle (12,935), Starclose Se Vascular Closure System (6,432) and Perclose ProGlide (3,552). 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.