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2026 data FDA MAUDE openFDA FDA Class II

Probe, Radiofrequency Lesion

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 §882.4725 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Probe, Radiofrequency Lesion LIGHT-BOOK · MAUDE

#693 of 1000 · 897 reports · 1996–2026

  • BOOK 897 reports
  • RANK #693 of 1000
  • DEATH 6 death-typed
  • INJ 323 injury-typed
  • MALF 549 malfunction
  • SPAN 1996–2026
  • PEAK 2017: 150
  • PHOTO Flow Cytometric Reage…

Nearest event-volume peer: Flow Cytometric Reagents And Accessories. (1 report gap)

Probe, Radiofrequency Lesion sits #693 of 1000 among tracked device types with 897 MAUDE reports spanning 1996–2026. 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 →

Injury-coded reports run above the device-type norm

Probe, Radiofrequency Lesion carries 36.0% INJURY-coded reports, 5.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 36.0% corpus 30.3% · above corpus mean (+5.7 pp)
  • MALF 61.2% corpus 64.8% · below corpus mean (-3.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 26% of coded problems · Lead manufacturer BOSTON SCIENTIFIC NEUROMODULATION accounts for 48% of manufacturer-tagged reports · Top event location I is 53% of location-tagged rows .

Probe, Radiofrequency Lesion in the event-volume neighbourhood

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

reports

What this shows Probe, Radiofrequency Lesion carries 897 MAUDE reports, ranked #693 of 1000.

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

Event Types

Malfunction 549 (61.2%)
Injury 323 (36.0%)
Other 16 (1.8%)
Death 6 (0.7%)
3 (0.3%)

Patient Outcomes

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

521 (56.9%)
Other 164 (17.9%)
Required Intervention 135 (14.7%)
Hospitalization 31 (3.4%)
R 23 (2.5%)
O 9 (1.0%)
Disability 8 (0.9%)
H 7 (0.8%)
Death 6 (0.7%)
S 5 (0.5%)
Life Threatening 4 (0.4%)
L 2 (0.2%)
D 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 219
Break 108
Material Separation 75
Material Discolored 53
Material Fragmentation 42
Device Misassembled During Manufacturing /Shipping 41
Insufficient Heating 40
Defective Device 37
Contamination /Decontamination Problem 30
Temperature Problem 30
Material Integrity Problem 29
Insufficient Device Problem Information 20
Nonstandard Device 20
Device Operates Differently Than Expected 19
Use of Device Problem 19
Fracture 18
Material Erosion 15
Leak/Splash 13
High impedance 11
Peeled/Delaminated 11

Yearly Trend

96
1996: 2
97
1997: 10
98
1998: 7
99
1999: 4
06
2006: 2
07
2007: 1
08
2008: 4
09
2009: 10
10
2010: 8
11
2011: 5
12
2012: 14
13
2013: 25
14
2014: 20
15
2015: 23
16
2016: 16
17
2017: 150
18
2018: 147
19
2019: 93
20
2020: 31
21
2021: 30
22
2022: 46
23
2023: 35
24
2024: 45
25
2025: 98
26
2026: 71

Reports rose to 98 in 2025, up from an average of 40 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Probe, Radiofrequency Lesion

Top Manufacturers

BOSTON SCIENTIFIC NEUROMODULATION 130
ST. JUDE MEDICAL, INC. 51
AVANOS MEDICAL INC. 42
STRYKER INSTRUMENTS-KALAMAZOO 29
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION 19

Event Locations

I 474 (52.8%)
384 (42.8%)
HOSPITAL 21 (2.3%)
AMBULATORY SURGICAL FACILITY 5 (0.6%)
OUTPATIENT TREATMENT FACILITY 5 (0.6%)
NO INFORMATION 2 (0.2%)
OTHER 2 (0.2%)
UNKNOWN 2 (0.2%)
INVALID DATA 1 (0.1%)
NOT APPLICABLE 1 (0.1%)

Compare BOSTON SCIENTIFIC NEUROMODULATION vs ST. JUDE MEDICAL, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Probe, Radiofrequency Lesion: 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 (897 here).

Flow Cytometric Reagents And Accessories. 896 Vitrectomy, Instrument Cutter 899 Laparoscopic Contraceptive Tubal Occlusion… 893 Unit, Cautery, Thermal, Ac-Powered 893

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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

Disclaimer: MAUDE figures for Probe, Radiofrequency Lesion 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, Radiofrequency Lesion; 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.