What are FDA adverse event reports for Catheter, Percutaneous?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Catheter, Percutaneous, there are 40,049 total reports including 869 death reports and 9,037 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Catheter, Percutaneous?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Catheter, Percutaneous

Name: Catheter, Percutaneous - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Catheter, Percutaneous MID-BOOK · MAUDE

#82 of 1000 · 40,049 reports · 1992–2026

BOOK 40,049 reports
RANK #82 of 1000
DEATH 869 death-typed
INJ 9,037 injury-typed
MALF 29,970 malfunction
SPAN 1992–2026
PEAK 2024: 3,191
PHOTO Unit

Nearest event-volume peer: Unit, Phacofragmentation (239 report gap)

Catheter, Percutaneous sits #82 of 1000 among tracked device types with 40,049 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 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
INJ 22.6% corpus 30.4% · below corpus mean (-7.9 pp)
MALF 74.8% corpus 64.5% · above corpus mean (+10.3 pp)

Lead product-problem code Material Rupture is 19% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 21% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Clip

41,375
Unit

40,288
Catheter (this)

40,049
Needle

39,044
Mesh

38,574
Filter

38,166

What this shows Catheter, Percutaneous carries 40,049 MAUDE reports, ranked #82 of 1000.

Event Types

Malfunction 29,970 (74.8%)

Injury 9,037 (22.6%)

Death 869 (2.2%)

Other 124 (0.3%)

49 (0.1%)

Patient Outcomes

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

29,217 (69.2%)

Required Intervention 5,175 (12.2%)

Other 2,768 (6.6%)

R 1,350 (3.2%)

Hospitalization 1,009 (2.4%)

Death 796 (1.9%)

Life Threatening 489 (1.2%)

O 358 (0.8%)

H 355 (0.8%)

L 268 (0.6%)

Disability 222 (0.5%)

D 118 (0.3%)

S 113 (0.3%)

Congenital Anomaly 7 (0.0%)

Yearly Trend

1992: 6

1993: 6

1994: 2

1995: 1

1996: 2

1997: 8

1999: 14

2000: 43

2001: 54

2002: 49

2003: 100

2004: 78

2005: 113

2006: 194

2007: 313

2008: 496

2009: 819

2010: 1,293

2011: 1,212

2012: 1,191

2013: 1,352

2014: 1,497

2015: 2,337

2016: 2,252

2017: 2,488

2018: 2,855

2019: 2,902

2020: 2,889

2021: 3,005

2022: 2,643

2023: 3,049

2024: 3,191

2025: 3,097

2026: 498

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 5,859

BARD PERIPHERAL VASCULAR, INC. 3,864

ARROW INTERNATIONAL INC. 3,691

BOSTON SCIENTIFIC - MAPLE GROVE 3,342

PENUMBRA, INC. 3,195

ARROW INTERNATIONAL LLC 2,920

MEDTRONIC IRELAND 2,349

COOK INC 1,044

MICRO THERAPEUTICS, INC. DBA EV3 822

ABBOTT MEDICAL 762

Event Locations

21,279 (53.1%)

I 16,625 (41.5%)

HOSPITAL 1,787 (4.5%)

NO INFORMATION 227 (0.6%)

OTHER 70 (0.2%)

UNKNOWN 19 (0.0%)

HOME 13 (0.0%)

OUTPATIENT TREATMENT FACILITY 13 (0.0%)

AMBULATORY SURGICAL FACILITY 4 (0.0%)

OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)

INVALID DATA 3 (0.0%)

NURSING HOME 3 (0.0%)

LABORATORY 1 (0.0%)

NOT APPLICABLE 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BARD PERIPHERAL VASCULAR, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Percutaneous, 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 (40,049 here).

Unit, Phacofragmentation 40,288 Needle, Hypodermic, Single Lumen 39,044 Clip, Implantable 41,375 Mesh 38,574

Similar death-typed counts

Nearest other device types by death-typed report count (869 here), distinct from the volume row.

Heart-Valve, Mechanical 883 Catheter, Thrombus Retriever 885 Wire, Guide, Catheter 895 Catheter, Coronary, Atherectomy 821

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

Disclaimer: MAUDE figures for Catheter, Percutaneous 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, Percutaneous; 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.

Catheter, Percutaneous

Event-type mix vs corpus