2026 data FDA MAUDE openFDA

Catheter, Steerable

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, Steerable MID-BOOK · MAUDE

#185 of 1000 · 12,715 reports · 1992–2026

  • BOOK 12,715 reports
  • RANK #185 of 1000
  • DEATH 236 death-typed
  • INJ 4,709 injury-typed
  • MALF 7,767 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 4,084
  • PHOTO Pulse-Generator

Nearest event-volume peer: Pulse-Generator, Pacemaker, External (56 report gap)

Catheter, Steerable sits #185 of 1000 among tracked device types with 12,715 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 1.9% corpus 1.5% · near corpus mean (+0.3 pp)
  • INJ 37.0% corpus 30.4% · above corpus mean (+6.6 pp)
  • MALF 61.1% corpus 64.5% · below corpus mean (-3.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 31% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Catheter, Steerable in the event-volume neighbourhood

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

reports

What this shows Catheter, Steerable carries 12,715 MAUDE reports, ranked #185 of 1000.

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

Event Types

Malfunction 7,767 (61.1%)
Injury 4,709 (37.0%)
Death 236 (1.9%)
Other 3 (0.0%)

Patient Outcomes

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

7,784 (51.3%)
Required Intervention 2,322 (15.3%)
R 1,315 (8.7%)
Hospitalization 1,107 (7.3%)
Other 862 (5.7%)
L 625 (4.1%)
Life Threatening 397 (2.6%)
H 391 (2.6%)
Death 207 (1.4%)
O 93 (0.6%)
S 30 (0.2%)
D 29 (0.2%)
Disability 18 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 3,738
Air/Gas in Device 2,749
Leak/Splash 2,129
Material Twisted/Bent 606
Gas/Air Leak 555
Material Integrity Problem 510
Fluid/Blood Leak 384
Device Contamination with Body Fluid 362
Air Leak 251
Break 228
Nonstandard Device 222
Appropriate Term/Code Not Available 206
Difficult to Advance 199
Deformation Due to Compressive Stress 186
Difficult to Insert 143
Failure to Advance 134
Suction Problem 127
Difficult to Remove 121
Mechanical Problem 115
Positioning Failure 114

Yearly Trend

92
1992: 3
01
2001: 2
03
2003: 2
04
2004: 2
06
2006: 1
07
2007: 6
08
2008: 23
09
2009: 5
10
2010: 2
11
2011: 155
12
2012: 89
13
2013: 113
14
2014: 212
15
2015: 350
16
2016: 481
17
2017: 625
18
2018: 633
19
2019: 700
20
2020: 703
21
2021: 741
22
2022: 652
23
2023: 788
24
2024: 1,962
25
2025: 4,084
26
2026: 381

Related Entities for Catheter, Steerable

Event Locations

8,410 (66.1%)
I 4,255 (33.5%)
HOSPITAL 33 (0.3%)
OTHER 11 (0.1%)
NO INFORMATION 6 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC CRYOCATH LP →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Steerable, 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 (12,715 here).

Similar death-typed counts

Nearest other device types by death-typed report count (236 here), distinct from the volume row.

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