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2026 data FDA MAUDE openFDA FDA Class II

Transducer, Pressure, Catheter Tip

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 §870.2870 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Transducer, Pressure, Catheter Tip LIGHT-BOOK · MAUDE

#457 of 1000 · 2,389 reports · 1992–2026

  • BOOK 2,389 reports
  • RANK #457 of 1000
  • DEATH 20 death-typed
  • INJ 419 injury-typed
  • MALF 1,934 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 197
  • PHOTO Electrode Measurement

Nearest event-volume peer: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (3 report gap)

Transducer, Pressure, Catheter Tip sits #457 of 1000 among tracked device types with 2,389 MAUDE reports spanning 1992–2026. 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, Pressure, Catheter Tip carries 81.0% MALFUNCTION-coded reports, 16.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 17.5% corpus 30.3% · below corpus mean (-12.8 pp)
  • MALF 81.0% corpus 64.8% · above corpus mean (+16.1 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 17% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 44% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Transducer, Pressure, Catheter Tip in the event-volume neighbourhood

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

reports

What this shows Transducer, Pressure, Catheter Tip carries 2,389 MAUDE reports, ranked #457 of 1000.

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

Event Types

Malfunction 1,934 (81.0%)
Injury 419 (17.5%)
Death 20 (0.8%)
11 (0.5%)
Other 5 (0.2%)

Patient Outcomes

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

1,913 (78.1%)
Required Intervention 268 (10.9%)
Other 119 (4.9%)
R 48 (2.0%)
Hospitalization 43 (1.8%)
Death 20 (0.8%)
O 17 (0.7%)
H 7 (0.3%)
Life Threatening 7 (0.3%)
Disability 4 (0.2%)
L 2 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 379
Detachment of Device or Device Component 291
Detachment Of Device Component 162
Break 159
Incorrect Measurement 141
Communication or Transmission Problem 127
Material Separation 124
Adverse Event Without Identified Device or Use Problem 115
Fracture 112
Device Contamination with Chemical or Other Material 93
Difficult to Remove 88
Contamination 79
Leak/Splash 78
Failure to Advance 66
Material Fragmentation 52
Fluid/Blood Leak 50
Deformation Due to Compressive Stress 41
Difficult to Advance 40
Improper or Incorrect Procedure or Method 39
Unsealed Device Packaging 38

Yearly Trend

92
1992: 2
99
1999: 3
01
2001: 1
02
2002: 1
03
2003: 1
07
2007: 3
08
2008: 2
09
2009: 8
10
2010: 74
11
2011: 111
12
2012: 82
13
2013: 93
14
2014: 85
15
2015: 114
16
2016: 152
17
2017: 186
18
2018: 179
19
2019: 153
20
2020: 158
21
2021: 116
22
2022: 144
23
2023: 194
24
2024: 197
25
2025: 183
26
2026: 147

Reports in 2025 (183) held close to the prior two-year average of 196.

Related Entities for Transducer, Pressure, Catheter Tip

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 264
ABBOTT VASCULAR 123
BOSTON SCIENTIFIC - MAPLE GROVE 88
EDWARDS LIFESCIENCES 67
EDWARDS LIFESCIENCES LLC 53

Event Locations

1,045 (43.7%)
I 908 (38.0%)
HOSPITAL 422 (17.7%)
NO INFORMATION 9 (0.4%)
OTHER 3 (0.1%)
HOSPICE 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs ABBOTT VASCULAR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Transducer, Pressure, Catheter Tip: 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 (2,389 here).

Electrode Measurement 2,392 Intervertebral Fusion Device With Integrate… 2,375 Electrode 2,372 Table, Operating-Room, Ac-Powered 2,406

Similar death-typed counts

Nearest other device types by death-typed report count (20 here), distinct from the volume row.

Accelerator, Linear, Medical 20 Set, I.V. Fluid Transfer 20 System 20 Apparatus 21

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

Disclaimer: MAUDE figures for Transducer, Pressure, Catheter Tip 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, Pressure, Catheter Tip; 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.