2026 data FDA MAUDE openFDA FDA Class II

Filter, Intravascular, Cardiovascular

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 §870.3375 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Filter, Intravascular, Cardiovascular MID-BOOK · MAUDE

#90 of 1000 · 38,320 reports · 1992–2026

  • BOOK 38,320 reports
  • RANK #90 of 1000
  • DEATH 929 death-typed
  • INJ 25,700 injury-typed
  • MALF 11,434 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 6,467
  • PHOTO Device

Nearest event-volume peer: Device, Impotence, Mechanical/Hydraulic (33 report gap)

Filter, Intravascular, Cardiovascular sits #90 of 1000 among tracked device types with 38,320 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 →

Injury-coded reports run above the device-type norm

Filter, Intravascular, Cardiovascular carries 67.1% INJURY-coded reports, 36.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.4% corpus 1.5% · above corpus mean (+0.9 pp)
  • INJ 67.1% corpus 30.3% · above corpus mean (+36.8 pp)
  • MALF 29.8% corpus 64.8% · below corpus mean (-35.0 pp)

Lead product-problem code Insufficient Device Problem Information is 14% of coded problems · Lead manufacturer WILLIAM COOK EUROPE accounts for 38% of manufacturer-tagged reports · Top event location I is 62% of location-tagged rows .

Filter, Intravascular, Cardiovascular in the event-volume neighbourhood

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

reports

What this shows Filter, Intravascular, Cardiovascular carries 38,320 MAUDE reports, ranked #90 of 1000.

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

Event Types

Injury 25,700 (67.1%)
Malfunction 11,434 (29.8%)
Death 929 (2.4%)
135 (0.4%)
Other 122 (0.3%)

Patient Outcomes

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

Life Threatening 18,834 (42.4%)
8,794 (19.8%)
Other 5,607 (12.6%)
Required Intervention 2,726 (6.1%)
O 2,245 (5.1%)
R 1,965 (4.4%)
Hospitalization 1,225 (2.8%)
L 1,161 (2.6%)
Death 964 (2.2%)
S 581 (1.3%)
H 129 (0.3%)
Disability 97 (0.2%)
D 43 (0.1%)
Congenital Anomaly 2 (0.0%)
Invalid Data 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Insufficient Device Problem Information 8,890
Difficult to Remove 7,575
Appropriate Device Problem Term/Code Not Available 6,084
Structural Problem 5,130
Malposition of Device 4,177
Unintended Movement 3,926
Migration or Expulsion of Device 3,672
Adverse Event Without Identified Device or Use Problem 2,995
Detachment of Device or Device Component 2,973
Fracture 2,805
Device Tipped Over 2,657
Patient Device Interaction Problem 2,444
Patient-Device Incompatibility 1,658
Failure to Align 1,596
Obstruction of Flow 1,560
Migration 1,190
Device remains implanted 781
Positioning Problem 775
Detachment Of Device Component 740
Extrusion 708

Yearly Trend

92
1992: 7
93
1993: 15
94
1994: 31
95
1995: 32
96
1996: 111
97
1997: 272
98
1998: 147
99
1999: 119
00
2000: 117
01
2001: 111
02
2002: 129
03
2003: 124
04
2004: 284
05
2005: 356
06
2006: 408
07
2007: 364
08
2008: 345
09
2009: 456
10
2010: 369
11
2011: 439
12
2012: 351
13
2013: 473
14
2014: 451
15
2015: 859
16
2016: 2,576
17
2017: 4,364
18
2018: 3,938
19
2019: 6,467
20
2020: 5,405
21
2021: 5,357
22
2022: 2,191
23
2023: 583
24
2024: 406
25
2025: 438
26
2026: 225

Reports in 2025 (438) held close to the prior two-year average of 495.

Related Entities for Filter, Intravascular, Cardiovascular

Event Locations

I 23,786 (62.1%)
10,255 (26.8%)
HOSPITAL 2,681 (7.0%)
OTHER 1,229 (3.2%)
NO INFORMATION 237 (0.6%)
INVALID DATA 69 (0.2%)
UNKNOWN 28 (0.1%)
HOME 27 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
NURSING HOME 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare WILLIAM COOK EUROPE vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Filter, Intravascular, Cardiovascular: 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 (38,320 here).

Similar death-typed counts

Nearest other device types by death-typed report count (929 here), distinct from the volume row.

Disclaimer: MAUDE figures for Filter, Intravascular, Cardiovascular 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 Filter, Intravascular, Cardiovascular; 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.