2026 data FDA MAUDE openFDA

Catheter, Coronary, 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, Coronary, Atherectomy MID-BOOK · MAUDE

#196 of 1000 · 11,401 reports · 1993–2026

  • BOOK 11,401 reports
  • RANK #196 of 1000
  • DEATH 821 death-typed
  • INJ 4,236 injury-typed
  • MALF 6,299 malfunction
  • SPAN 1993–2026
  • PEAK 2021: 901
  • PHOTO Mesh, Surgical

Nearest event-volume peer: Mesh, Surgical (120 report gap)

Catheter, Coronary, Atherectomy sits #196 of 1000 among tracked device types with 11,401 MAUDE reports spanning 1993–2026. 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 7.2% corpus 1.5% · above corpus mean (+5.7 pp)
  • INJ 37.2% corpus 30.4% · above corpus mean (+6.7 pp)
  • MALF 55.2% corpus 64.5% · below corpus mean (-9.3 pp)

Lead product-problem code Entrapment of Device is 24% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 57% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Catheter, Coronary, Atherectomy in the event-volume neighbourhood

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

reports

What this shows Catheter, Coronary, Atherectomy carries 11,401 MAUDE reports, ranked #196 of 1000.

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

Event Types

Malfunction 6,299 (55.2%)
Injury 4,236 (37.2%)
Death 821 (7.2%)
Other 29 (0.3%)
16 (0.1%)

Patient Outcomes

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

6,260 (50.4%)
Required Intervention 2,744 (22.1%)
Other 1,078 (8.7%)
Death 794 (6.4%)
R 671 (5.4%)
Hospitalization 296 (2.4%)
Life Threatening 162 (1.3%)
H 120 (1.0%)
O 116 (0.9%)
L 79 (0.6%)
D 45 (0.4%)
Disability 41 (0.3%)
S 11 (0.1%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Entrapment of Device 2,076
Adverse Event Without Identified Device or Use Problem 1,676
Material Separation 820
Detachment of Device or Device Component 597
Output Problem 536
Device Damaged by Another Device 480
Fracture 458
Difficult to Remove 305
Intermittent Loss of Power 215
Failure to Advance 198
Material Deformation 184
Material Integrity Problem 175
Break 168
Mechanical Problem 160
Unintended System Motion 143
No Display/Image 134
Detachment Of Device Component 130
Device Operates Differently Than Expected 126
Noise, Audible 121
Difficult to Advance 107

Yearly Trend

93
1993: 7
94
1994: 17
95
1995: 12
96
1996: 27
97
1997: 54
98
1998: 21
99
1999: 28
00
2000: 21
01
2001: 20
02
2002: 19
03
2003: 34
04
2004: 58
05
2005: 65
06
2006: 59
07
2007: 107
08
2008: 185
09
2009: 289
10
2010: 319
11
2011: 333
12
2012: 293
13
2013: 355
14
2014: 412
15
2015: 629
16
2016: 713
17
2017: 735
18
2018: 876
19
2019: 788
20
2020: 822
21
2021: 901
22
2022: 720
23
2023: 706
24
2024: 798
25
2025: 873
26
2026: 105

Related Entities for Catheter, Coronary, Atherectomy

Event Locations

5,992 (52.6%)
I 4,836 (42.4%)
HOSPITAL 377 (3.3%)
UNKNOWN 67 (0.6%)
OTHER 64 (0.6%)
NO INFORMATION 49 (0.4%)
INVALID DATA 11 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - CORK →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Coronary, 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 (11,401 here).

Similar death-typed counts

Nearest other device types by death-typed report count (821 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Coronary, 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, Coronary, 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.