2026 data FDA MAUDE openFDA FDA Class II

Device, Anastomotic, Microvascular

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.4300 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Device, Anastomotic, Microvascular LIGHT-BOOK · MAUDE

#827 of 1000 · 601 reports · 2006–2026

  • BOOK 601 reports
  • RANK #827 of 1000
  • DEATH 0 death-typed
  • INJ 147 injury-typed
  • MALF 448 malfunction
  • SPAN 2006–2026
  • PEAK 2025: 92
  • PHOTO Suture, Nonabsorbable

Nearest event-volume peer: Suture, Nonabsorbable (0 report gap)

Device, Anastomotic, Microvascular sits #827 of 1000 among tracked device types with 601 MAUDE reports spanning 2006–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Device, Anastomotic, Microvascular carries 74.5% MALFUNCTION-coded reports, 9.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 24.5% corpus 30.3% · below corpus mean (-5.8 pp)
  • MALF 74.5% corpus 64.8% · above corpus mean (+9.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 16% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 100% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Device, Anastomotic, Microvascular in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Device, Anastomotic, Microvascular carries 601 MAUDE reports, ranked #827 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 448 (74.5%)
Injury 147 (24.5%)
Other 6 (1.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

431 (72.2%)
Required Intervention 91 (15.2%)
Other 64 (10.7%)
R 6 (1.0%)
Hospitalization 4 (0.7%)
S 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 91
Device Operates Differently Than Expected 75
Disconnection 58
Material Twisted/Bent 49
Detachment of Device or Device Component 45
Difficult to Open or Close 45
Device Slipped 26
Failure to Align 25
Device Dislodged or Dislocated 24
Break 22
Detachment Of Device Component 16
Fitting Problem 15
Insufficient Device Problem Information 15
Component Falling 13
Incomplete or Inadequate Connection 12
Loose or Intermittent Connection 9
Bent 8
Material Separation 8
Misconnection 8
Activation, Positioning or Separation Problem 6

Yearly Trend

06
2006: 3
07
2007: 1
08
2008: 12
09
2009: 23
10
2010: 31
11
2011: 28
12
2012: 29
13
2013: 21
14
2014: 26
15
2015: 40
16
2016: 22
17
2017: 13
18
2018: 13
19
2019: 44
20
2020: 43
21
2021: 35
22
2022: 18
23
2023: 28
24
2024: 38
25
2025: 92
26
2026: 41

Reports rose to 92 in 2025, up from an average of 33 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Device, Anastomotic, Microvascular

Event Locations

393 (65.4%)
I 187 (31.1%)
HOSPITAL 18 (3.0%)
NO INFORMATION 3 (0.5%)

Compare BAXTER HEALTHCARE CORPORATION vs BAXTER INTERNATIONAL INC. →

Nationwide devices with a comparable report-volume footprint

Device, Anastomotic, Microvascular carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (601 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Anastomotic, Microvascular are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Device, Anastomotic, Microvascular; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.