MICROVENTION, INC.

FDA MAUDE device safety record · 2002–2026

What the Data Shows About MICROVENTION, INC.

MICROVENTION, INC. is associated with 5,107 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2026. Of the total, 150 are coded as death reports and 2,289 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 17 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MICROVENTION, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 2,660 reports (52.1% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 25 years of MAUDE data, with the peak single-year volume reaching 768 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

5,107
Total Reports
150
Death Reports
2,289
Injury Reports
17
Device Types

Event Types

Malfunction 2,660 (52.1%)
Injury 2,289 (44.8%)
Death 150 (2.9%)
5 (0.1%)
Other 3 (0.1%)

Patient Outcomes

2,515 (46.7%)
Required Intervention 1,664 (30.9%)
Other 496 (9.2%)
R 177 (3.3%)
Death 138 (2.6%)
Hospitalization 72 (1.3%)
Disability 68 (1.3%)
S 65 (1.2%)
Life Threatening 64 (1.2%)
O 63 (1.2%)
L 26 (0.5%)
H 24 (0.4%)
D 10 (0.2%)
Congenital Anomaly 3 (0.1%)

Yearly Trend

02
2002: 18
03
2003: 15
04
2004: 22
05
2005: 7
06
2006: 10
07
2007: 15
08
2008: 33
09
2009: 61
10
2010: 35
11
2011: 43
12
2012: 56
13
2013: 90
14
2014: 122
15
2015: 230
16
2016: 289
17
2017: 326
18
2018: 284
19
2019: 249
20
2020: 371
21
2021: 503
22
2022: 385
23
2023: 431
24
2024: 611
25
2025: 768
26
2026: 133

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.