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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Recording, Electrode, Reprocessed

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 §870.1220 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Catheter, Recording, Electrode, Reprocessed LIGHT-BOOK · MAUDE

#930 of 1000 · 449 reports · 2004–2026

  • BOOK 449 reports
  • RANK #930 of 1000
  • DEATH 1 death-typed
  • INJ 66 injury-typed
  • MALF 381 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 66
  • PHOTO Blood Grouping Reagent

Nearest event-volume peer: Blood Grouping Reagent (2 report gap)

Catheter, Recording, Electrode, Reprocessed sits #930 of 1000 among tracked device types with 449 MAUDE reports spanning 2004–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Catheter, Recording, Electrode, Reprocessed carries 84.9% MALFUNCTION-coded reports, 20.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 14.7% corpus 30.3% · below corpus mean (-15.6 pp)
  • MALF 84.9% corpus 64.8% · above corpus mean (+20.0 pp)

Lead product-problem code Use of Device Problem is 23% of coded problems · Top event location is 53% of location-tagged rows .

Catheter, Recording, Electrode, Reprocessed in the event-volume neighbourhood

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

reports

What this shows Catheter, Recording, Electrode, Reprocessed carries 449 MAUDE reports, ranked #930 of 1000.

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

Event Types

Malfunction 381 (84.9%)
Injury 66 (14.7%)
1 (0.2%)
Death 1 (0.2%)

Patient Outcomes

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

380 (78.7%)
Required Intervention 23 (4.8%)
R 21 (4.3%)
Other 17 (3.5%)
Hospitalization 12 (2.5%)
L 11 (2.3%)
Life Threatening 11 (2.3%)
H 5 (1.0%)
O 1 (0.2%)
S 1 (0.2%)
Death 1 (0.2%)

Top Product Problems

Use of Device Problem 107
Mechanical Problem 66
Material Deformation 53
Mechanical Jam 37
Break 22
Kinked 22
Positioning Problem 20
Defective Device 17
Difficult to Remove 17
Device Operates Differently Than Expected 15
Adverse Event Without Identified Device or Use Problem 12
Deformation Due to Compressive Stress 11
Inadequacy of Device Shape and/or Size 11
Device Damaged Prior to Receipt by User 10
Entrapment of Device 10
Patient Device Interaction Problem 10
Bent 9
Insufficient Device Problem Information 9
Material Separation 9
Signal Artifact/Noise 8

Yearly Trend

04
2004: 1
06
2006: 3
07
2007: 1
09
2009: 1
10
2010: 8
11
2011: 10
12
2012: 9
13
2013: 6
14
2014: 17
15
2015: 34
16
2016: 25
17
2017: 11
18
2018: 21
19
2019: 38
20
2020: 28
21
2021: 55
22
2022: 12
23
2023: 30
24
2024: 47
25
2025: 66
26
2026: 26

Reports rose to 66 in 2025, up from an average of 39 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Recording, Electrode, Reprocessed

Event Locations

240 (53.5%)
I 171 (38.1%)
HOSPITAL 30 (6.7%)
OTHER 7 (1.6%)
NO INFORMATION 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Recording, Electrode, Reprocessed: 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 (449 here).

Blood Grouping Reagent 451 Tray, Surgical 452 Shockwave Intravascular Lithotripsy System 445 Shunt, Portosystemic, Endoprosthesis 444

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Catheter, Recording, Electrode, Reprocessed 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, Recording, Electrode, Reprocessed; 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.