2026 data FDA MAUDE openFDA

Wire, Guide, Catheter

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 Wire, Guide, Catheter MID-BOOK · MAUDE

#99 of 1000 · 32,823 reports · 1992–2026

  • BOOK 32,823 reports
  • RANK #99 of 1000
  • DEATH 895 death-typed
  • INJ 12,773 injury-typed
  • MALF 18,855 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 2,210
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Elastomeric (2 report gap)

Wire, Guide, Catheter sits #99 of 1000 among tracked device types with 32,823 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 →

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 2.7% corpus 1.5% · above corpus mean (+1.2 pp)
  • INJ 38.9% corpus 30.4% · above corpus mean (+8.5 pp)
  • MALF 57.4% corpus 64.5% · below corpus mean (-7.1 pp)

Lead product-problem code Material Separation is 11% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 24% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Wire, Guide, Catheter in the event-volume neighbourhood

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

reports

What this shows Wire, Guide, Catheter carries 32,823 MAUDE reports, ranked #99 of 1000.

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

Event Types

Malfunction 18,855 (57.4%)
Injury 12,773 (38.9%)
Death 895 (2.7%)
Other 162 (0.5%)
136 (0.4%)
No answer provided 2 (0.0%)

Patient Outcomes

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

18,390 (51.2%)
Required Intervention 6,760 (18.8%)
Other 4,534 (12.6%)
R 1,706 (4.8%)
Hospitalization 1,191 (3.3%)
Death 831 (2.3%)
Disability 642 (1.8%)
S 480 (1.3%)
Life Threatening 424 (1.2%)
O 359 (1.0%)
L 314 (0.9%)
H 137 (0.4%)
D 104 (0.3%)
Invalid Data 12 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Material Separation 2,393
Difficult to Remove 2,358
Break 1,955
Fracture 1,560
Adverse Event Without Identified Device or Use Problem 1,478
Detachment of Device or Device Component 1,473
Peeled/Delaminated 1,450
Difficult to Advance 1,387
Entrapment of Device 1,101
Detachment Of Device Component 893
Failure to Advance 745
Stretched 620
Material Deformation 607
Unraveled Material 573
Material Integrity Problem 521
Deformation Due to Compressive Stress 480
Improper or Incorrect Procedure or Method 424
Physical Resistance/Sticking 421
Insufficient Information 412
Material Split, Cut or Torn 388

Yearly Trend

92
1992: 44
93
1993: 33
94
1994: 75
95
1995: 54
96
1996: 180
97
1997: 432
98
1998: 377
99
1999: 265
00
2000: 231
01
2001: 247
02
2002: 291
03
2003: 422
04
2004: 610
05
2005: 649
06
2006: 886
07
2007: 760
08
2008: 715
09
2009: 687
10
2010: 987
11
2011: 1,312
12
2012: 1,337
13
2013: 1,474
14
2014: 1,323
15
2015: 1,323
16
2016: 1,465
17
2017: 1,524
18
2018: 1,737
19
2019: 1,679
20
2020: 1,536
21
2021: 1,713
22
2022: 1,647
23
2023: 2,068
24
2024: 2,210
25
2025: 2,202
26
2026: 328

Related Entities for Wire, Guide, Catheter

Event Locations

17,689 (53.9%)
I 8,885 (27.1%)
HOSPITAL 4,255 (13.0%)
UNKNOWN 850 (2.6%)
OTHER 653 (2.0%)
NO INFORMATION 303 (0.9%)
INVALID DATA 80 (0.2%)
NOT APPLICABLE 75 (0.2%)
AMBULATORY SURGICAL FACILITY 9 (0.0%)
HOME 9 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.0%)
OUTPATIENT TREATMENT FACILITY 6 (0.0%)
CATHETERIZATION SUITE 3 (0.0%)

Compare AV-TEMECULA-CT vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Wire, Guide, Catheter, 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 (32,823 here).

Similar death-typed counts

Nearest other device types by death-typed report count (895 here), distinct from the volume row.

Disclaimer: MAUDE figures for Wire, Guide, Catheter 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 Wire, Guide, Catheter; 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.