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2026 data FDA MAUDE openFDA FDA Class I

Catheter, Balloon Type

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4200 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Catheter, Balloon Type LIGHT-BOOK · MAUDE

#759 of 1000 · 751 reports · 1992–2026

  • BOOK 751 reports
  • RANK #759 of 1000
  • DEATH 55 death-typed
  • INJ 271 injury-typed
  • MALF 416 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 67
  • PHOTO Extractor

Nearest event-volume peer: Extractor, Vacuum, Fetal (0 report gap)

Catheter, Balloon Type sits #759 of 1000 among tracked device types with 751 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 →

Malfunction reports sit below the device-type norm

Catheter, Balloon Type carries 55.4% MALFUNCTION-coded reports, 9.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.3% corpus 1.5% · above corpus mean (+5.8 pp)
  • INJ 36.1% corpus 30.3% · above corpus mean (+5.8 pp)
  • MALF 55.4% corpus 64.8% · below corpus mean (-9.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 33% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - MAPLE GROVE accounts for 46% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Catheter, Balloon Type in the event-volume neighbourhood

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

reports

What this shows Catheter, Balloon Type carries 751 MAUDE reports, ranked #759 of 1000.

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

Event Types

Malfunction 416 (55.4%)
Injury 271 (36.1%)
Death 55 (7.3%)
5 (0.7%)
Other 4 (0.5%)

Patient Outcomes

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

387 (45.9%)
Other 187 (22.2%)
Required Intervention 104 (12.3%)
R 64 (7.6%)
Death 54 (6.4%)
O 22 (2.6%)
Hospitalization 11 (1.3%)
S 4 (0.5%)
Invalid Data 4 (0.5%)
Disability 3 (0.4%)
D 2 (0.2%)
H 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 232
Leak/Splash 114
Fluid/Blood Leak 62
Incorrect Measurement 58
Other (for use when an appropriate device code cannot be identified) 45
Material Rupture 35
Display or Visual Feedback Problem 31
Balloon rupture 16
Inflation Problem 13
Break 12
Hole In Material 10
Air Leak 8
Burst Container or Vessel 8
Deflation Problem 8
Material Puncture/Hole 8
Material Separation 8
Unknown (for use when the device problem is not known) 8
Difficult to Remove 7
Replace 7
Balloon burst 6

Yearly Trend

92
1992: 17
93
1993: 13
94
1994: 8
95
1995: 3
96
1996: 5
97
1997: 17
98
1998: 8
99
1999: 4
00
2000: 4
01
2001: 2
02
2002: 1
03
2003: 4
04
2004: 2
05
2005: 6
06
2006: 6
07
2007: 7
08
2008: 33
09
2009: 42
10
2010: 45
11
2011: 60
12
2012: 43
13
2013: 36
14
2014: 22
15
2015: 67
16
2016: 64
17
2017: 51
18
2018: 34
19
2019: 15
20
2020: 13
21
2021: 20
22
2022: 27
23
2023: 22
24
2024: 16
25
2025: 23
26
2026: 11

Reports in 2025 (23) held close to the prior two-year average of 19.

Related Entities for Catheter, Balloon Type

Top Manufacturers

BOSTON SCIENTIFIC - MAPLE GROVE 112
BOSTON SCIENTIFIC - MARLBOROUGH 58
BOSTON SCIENTIFIC CORPORATION 45
BOSTON SCIENTIFIC CORP. 11
TELEFLEX MEDICAL 9
BOSTON SCIENTIFIC 6

Event Locations

456 (60.7%)
I 218 (29.0%)
HOSPITAL 53 (7.1%)
INVALID DATA 16 (2.1%)
OTHER 4 (0.5%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
HOME 1 (0.1%)
NURSING HOME 1 (0.1%)

Compare BOSTON SCIENTIFIC - MAPLE GROVE vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Balloon Type: 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 (751 here).

Extractor, Vacuum, Fetal 751 Catheter, Balloon, Transcervical 753 Device, Intravascular Catheter Securement 749 Osteotome 749

Similar death-typed counts

Nearest other device types by death-typed report count (55 here), distinct from the volume row.

Bottle, Collection, Vacuum 55 Orthopedic Manual Surgical Instrument 55 Stent, Metallic, Expandable, Duodenal 55 Wheelchair, Mechanical 55

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

Disclaimer: MAUDE figures for Catheter, Balloon Type 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, Balloon Type; 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.