2026 data FDA MAUDE openFDA

Catheter, Peripheral, Atherectomy

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 MAUDE casebook

openFDA event book Catheter, Peripheral, Atherectomy LIGHT-BOOK · MAUDE

#238 of 1000 · 8,008 reports · 1994–2026

  • BOOK 8,008 reports
  • RANK #238 of 1000
  • DEATH 126 death-typed
  • INJ 3,304 injury-typed
  • MALF 4,425 malfunction
  • SPAN 1994–2026
  • PEAK 2021: 734
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Soft Lens Products (15 report gap)

Catheter, Peripheral, Atherectomy sits #238 of 1000 among tracked device types with 8,008 MAUDE reports spanning 1994–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.6% corpus 1.5% · near corpus mean (+0.1 pp)
  • INJ 41.3% corpus 30.4% · above corpus mean (+10.8 pp)
  • MALF 55.3% corpus 64.5% · below corpus mean (-9.2 pp)

Lead product-problem code Break is 14% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 35% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Catheter, Peripheral, Atherectomy in the event-volume neighbourhood

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

reports

What this shows Catheter, Peripheral, Atherectomy carries 8,008 MAUDE reports, ranked #238 of 1000.

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

Event Types

Malfunction 4,425 (55.3%)
Injury 3,304 (41.3%)
Other 131 (1.6%)
Death 126 (1.6%)
22 (0.3%)

Patient Outcomes

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

4,227 (50.4%)
Required Intervention 2,468 (29.4%)
Other 917 (10.9%)
R 244 (2.9%)
Hospitalization 183 (2.2%)
Death 122 (1.5%)
Life Threatening 63 (0.8%)
O 49 (0.6%)
S 31 (0.4%)
H 29 (0.3%)
L 29 (0.3%)
Disability 11 (0.1%)
D 8 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Break 1,028
Detachment of Device or Device Component 1,005
Adverse Event Without Identified Device or Use Problem 937
Entrapment of Device 893
Material Separation 505
Material Deformation 483
Mechanical Jam 366
Difficult to Remove 351
Physical Resistance/Sticking 287
Mechanical Problem 252
Suction Problem 200
Fracture 167
Device Damaged by Another Device 142
Difficult to Advance 128
Noise, Audible 123
Leak/Splash 111
Retraction Problem 96
Aspiration Issue 89
Failure to Advance 78
Use of Device Problem 72

Yearly Trend

94
1994: 6
96
1996: 1
97
1997: 23
98
1998: 47
99
1999: 36
00
2000: 29
01
2001: 14
02
2002: 24
03
2003: 38
04
2004: 36
05
2005: 99
06
2006: 110
07
2007: 50
08
2008: 115
09
2009: 105
10
2010: 167
11
2011: 204
12
2012: 194
13
2013: 134
14
2014: 210
15
2015: 377
16
2016: 409
17
2017: 415
18
2018: 537
19
2019: 618
20
2020: 631
21
2021: 734
22
2022: 566
23
2023: 574
24
2024: 677
25
2025: 688
26
2026: 140

Related Entities for Catheter, Peripheral, Atherectomy

Event Locations

4,450 (55.6%)
I 3,173 (39.6%)
HOSPITAL 288 (3.6%)
NO INFORMATION 66 (0.8%)
NOT APPLICABLE 12 (0.1%)
UNKNOWN 12 (0.1%)
OTHER 3 (0.0%)
INVALID DATA 2 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC IRELAND →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Peripheral, Atherectomy, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (8,008 here).

Similar death-typed counts

Nearest other device types by death-typed report count (126 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Peripheral, Atherectomy 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, Peripheral, Atherectomy; 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.