2026 data FDA MAUDE openFDA FDA Class II

Probe, Blood-Flow, Extravascular

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 §870.2120 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Probe, Blood-Flow, Extravascular LIGHT-BOOK · MAUDE

#973 of 1000 · 398 reports · 1997–2026

  • BOOK 398 reports
  • RANK #973 of 1000
  • DEATH 7 death-typed
  • INJ 16 injury-typed
  • MALF 375 malfunction
  • SPAN 1997–2026
  • PEAK 2024: 169
  • PHOTO Device

Nearest event-volume peer: Device, Percutaneous Retrieval (0 report gap)

Probe, Blood-Flow, Extravascular sits #973 of 1000 among tracked device types with 398 MAUDE reports spanning 1997–2026. 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

Probe, Blood-Flow, Extravascular carries 94.2% MALFUNCTION-coded reports, 29.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
  • INJ 4.0% corpus 30.3% · below corpus mean (-26.3 pp)
  • MALF 94.2% corpus 64.8% · above corpus mean (+29.4 pp)

Lead product-problem code Fluid/Blood Leak is 25% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 87% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .

Probe, Blood-Flow, Extravascular in the event-volume neighbourhood

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

reports

What this shows Probe, Blood-Flow, Extravascular carries 398 MAUDE reports, ranked #973 of 1000.

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

Event Types

Malfunction 375 (94.2%)
Injury 16 (4.0%)
Death 7 (1.8%)

Patient Outcomes

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

358 (88.4%)
Other 16 (4.0%)
Required Intervention 12 (3.0%)
Death 8 (2.0%)
R 4 (1.0%)
L 2 (0.5%)
Hospitalization 2 (0.5%)
Life Threatening 2 (0.5%)
O 1 (0.2%)

Top Product Problems

Fluid/Blood Leak 111
Leak/Splash 58
Unable to Obtain Readings 45
Incorrect, Inadequate or Imprecise Result or Readings 31
Failure to Calibrate 19
Gas/Air Leak 19
Display or Visual Feedback Problem 15
Replace 15
Break 13
Crack 13
Data Problem 13
Failure to Zero 13
Failure to Sense 12
Device Sensing Problem 10
Air/Gas in Device 9
Loose or Intermittent Connection 9
No Display/Image 9
Detachment of Device or Device Component 8
Disconnection 8
Pressure Problem 7

Yearly Trend

97
1997: 2
98
1998: 4
99
1999: 3
00
2000: 3
01
2001: 2
02
2002: 2
03
2003: 2
04
2004: 2
05
2005: 2
06
2006: 3
07
2007: 5
08
2008: 1
09
2009: 3
10
2010: 3
11
2011: 3
12
2012: 1
14
2014: 5
18
2018: 3
19
2019: 1
20
2020: 3
21
2021: 13
22
2022: 46
23
2023: 21
24
2024: 169
25
2025: 53
26
2026: 43

Reports fell to 53 in 2025, down from an average of 95 in the two years before.

Related Entities for Probe, Blood-Flow, Extravascular

Event Locations

353 (88.7%)
HOSPITAL 32 (8.0%)
I 12 (3.0%)
NO INFORMATION 1 (0.3%)

Compare SMITHS MEDICAL ASD, INC. vs ICU MEDICAL, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Probe, Blood-Flow, Extravascular: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (398 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for Probe, Blood-Flow, Extravascular 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 Probe, Blood-Flow, Extravascular; 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.