PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Catheter, Oximeter, Fiber-Optic

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 §870.1230 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Catheter, Oximeter, Fiber-Optic LIGHT-BOOK · MAUDE

#650 of 1000 · 1,067 reports · 1992–2026

  • BOOK 1,067 reports
  • RANK #650 of 1000
  • DEATH 24 death-typed
  • INJ 123 injury-typed
  • MALF 901 malfunction
  • SPAN 1992–2026
  • PEAK 2012: 79
  • PHOTO Occluder

Nearest event-volume peer: Occluder, Patent Ductus, Arteriosus (4 report gap)

Catheter, Oximeter, Fiber-Optic sits #650 of 1000 among tracked device types with 1,067 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

Catheter, Oximeter, Fiber-Optic carries 84.4% MALFUNCTION-coded reports, 19.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 11.5% corpus 30.3% · below corpus mean (-18.8 pp)
  • MALF 84.4% corpus 64.8% · above corpus mean (+19.6 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 17% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 58% of manufacturer-tagged reports · Top event location HOSPITAL is 36% of location-tagged rows .

Catheter, Oximeter, Fiber-Optic in the event-volume neighbourhood

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

reports

What this shows Catheter, Oximeter, Fiber-Optic carries 1,067 MAUDE reports, ranked #650 of 1000.

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

Event Types

Malfunction 901 (84.4%)
Injury 123 (11.5%)
Death 24 (2.2%)
Other 14 (1.3%)
5 (0.5%)

Patient Outcomes

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

836 (77.0%)
Other 140 (12.9%)
Required Intervention 45 (4.1%)
Death 26 (2.4%)
R 9 (0.8%)
Hospitalization 8 (0.7%)
Life Threatening 6 (0.6%)
L 5 (0.5%)
H 4 (0.4%)
Disability 4 (0.4%)
O 3 (0.3%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 169
Material Rupture 98
Leak/Splash 66
Incorrect Measurement 63
Appropriate Device Problem Term/Code Not Available 58
Fluid/Blood Leak 54
Adverse Event Without Identified Device or Use Problem 51
Difficult to Insert 50
Replace 42
Deflation Problem 41
Difficult to Remove 36
Inflation Problem 35
Balloon rupture 34
Break 33
Device Contamination with Chemical or Other Material 33
Unable to Obtain Readings 28
Device, removal of (non-implant) 25
Material Frayed 19
Measurements, inaccurate 19
Other (for use when an appropriate device code cannot be identified) 19

Yearly Trend

92
1992: 1
96
1996: 3
97
1997: 18
98
1998: 18
99
1999: 16
00
2000: 24
01
2001: 13
02
2002: 16
03
2003: 10
04
2004: 4
05
2005: 3
06
2006: 5
07
2007: 20
08
2008: 12
09
2009: 51
10
2010: 64
11
2011: 54
12
2012: 79
13
2013: 58
14
2014: 38
15
2015: 58
16
2016: 68
17
2017: 47
18
2018: 38
19
2019: 63
20
2020: 39
21
2021: 39
22
2022: 57
23
2023: 48
24
2024: 47
25
2025: 31
26
2026: 25

Reports in 2025 (31) held close to the prior two-year average of 48.

Related Entities for Catheter, Oximeter, Fiber-Optic

Top Manufacturers

EDWARDS LIFESCIENCES, PR 563
EDWARDS LIFESCIENCES PR 140
ABBOTT LABORATORIES 106
ICU MEDICAL, INC. 75
EDWARDS LIFESCIENCES 56
EDWARDS LIFESCIENCES LLC 21
HOSPIRA, INC. 11
ICU MEDICAL INC. 6

Event Locations

HOSPITAL 389 (36.5%)
371 (34.8%)
I 296 (27.7%)
NO INFORMATION 6 (0.6%)
UNKNOWN 3 (0.3%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)

Compare EDWARDS LIFESCIENCES, PR vs EDWARDS LIFESCIENCES PR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Oximeter, Fiber-Optic: 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 (1,067 here).

Occluder, Patent Ductus, Arteriosus 1,071 System, Dialysate Delivery, Single Patient 1,072 Hemostatic Device For Endoscopic Gastrointe… 1,077 Introducer, Syringe Needle 1,079

Similar death-typed counts

Nearest other device types by death-typed report count (24 here), distinct from the volume row.

Apparatus, Suction, Patient Care 24 Chair, Positioning, Electric 24 Laparoscope, Gynecologic 24 Mesh 24

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

Disclaimer: MAUDE figures for Catheter, Oximeter, Fiber-Optic 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 Catheter, Oximeter, Fiber-Optic; 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.