PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Transducer, Blood-Pressure, 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 §870.2850 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Transducer, Blood-Pressure, Extravascular LIGHT-BOOK · MAUDE

#357 of 1000 · 3,904 reports · 1993–2026

  • BOOK 3,904 reports
  • RANK #357 of 1000
  • DEATH 25 death-typed
  • INJ 250 injury-typed
  • MALF 3,495 malfunction
  • SPAN 1993–2026
  • PEAK 2008: 531
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) (19 report gap)

Transducer, Blood-Pressure, Extravascular sits #357 of 1000 among tracked device types with 3,904 MAUDE reports spanning 1993–2026. 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

Transducer, Blood-Pressure, Extravascular carries 89.5% MALFUNCTION-coded reports, 24.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 6.4% corpus 30.3% · below corpus mean (-23.9 pp)
  • MALF 89.5% corpus 64.8% · above corpus mean (+24.7 pp)

Lead product-problem code Detachment Of Device Component is 14% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 36% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Transducer, Blood-Pressure, Extravascular in the event-volume neighbourhood

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

reports

What this shows Transducer, Blood-Pressure, Extravascular carries 3,904 MAUDE reports, ranked #357 of 1000.

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

Event Types

Malfunction 3,495 (89.5%)
Injury 250 (6.4%)
Other 98 (2.5%)
36 (0.9%)
Death 25 (0.6%)

Patient Outcomes

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

3,045 (76.7%)
Other 610 (15.4%)
Required Intervention 147 (3.7%)
Life Threatening 56 (1.4%)
R 51 (1.3%)
Death 22 (0.6%)
Hospitalization 15 (0.4%)
Disability 8 (0.2%)
O 6 (0.2%)
L 5 (0.1%)
D 2 (0.1%)
S 2 (0.1%)
Congenital Anomaly 2 (0.1%)
Invalid Data 1 (0.0%)

Top Product Problems

Detachment Of Device Component 475
Fluid/Blood Leak 404
Leak/Splash 391
Break 318
Material Separation 314
Disconnection 266
Crack 180
Replace 176
Air Leak 170
Incorrect, Inadequate or Imprecise Result or Readings 98
Component(s), broken 75
Backflow 63
Incorrect Measurement 59
Unable to Obtain Readings 56
Contamination 53
Loose or Intermittent Connection 52
Drift 47
High Readings 43
Air/Gas in Device 41
Excess Flow or Over-Infusion 41

Yearly Trend

93
1993: 3
94
1994: 11
95
1995: 20
96
1996: 33
97
1997: 188
98
1998: 110
99
1999: 81
00
2000: 75
01
2001: 72
02
2002: 73
03
2003: 101
04
2004: 137
05
2005: 85
06
2006: 79
07
2007: 397
08
2008: 531
09
2009: 344
10
2010: 115
11
2011: 63
12
2012: 43
13
2013: 39
14
2014: 23
15
2015: 60
16
2016: 89
17
2017: 92
18
2018: 82
19
2019: 84
20
2020: 41
21
2021: 93
22
2022: 95
23
2023: 147
24
2024: 205
25
2025: 191
26
2026: 102

Reports in 2025 (191) held close to the prior two-year average of 176.

Related Entities for Transducer, Blood-Pressure, Extravascular

Top Manufacturers

EDWARDS LIFESCIENCES 708
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 666
ABBOTT LABORATORIES 254
ICU MEDICAL, INC. 207
SMITHS MEDICAL ASD, INC. 130

Event Locations

2,095 (53.7%)
HOSPITAL 1,216 (31.1%)
I 455 (11.7%)
INVALID DATA 92 (2.4%)
NO INFORMATION 19 (0.5%)
OTHER 14 (0.4%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
UNKNOWN 5 (0.1%)
NOT APPLICABLE 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare EDWARDS LIFESCIENCES vs ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Transducer, Blood-Pressure, 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 (3,904 here).

Prosthesis, Hip, Semi-Constrained 3,885 File, Pulp Canal, Endodontic 3,925 Collector 3,860 Transducer, Ultrasonic, Diagnostic 3,948

Similar death-typed counts

Nearest other device types by death-typed report count (25 here), distinct from the volume row.

Aid, Transfer 25 Analyzer, Chemistry, For Clinical Use 25 Hemostatic Metal Clip For The Gi Tract 25 Shunt, Portosystemic, Endoprosthesis 25

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Transducer, Blood-Pressure, 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 Transducer, Blood-Pressure, 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.