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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Retention Type, Balloon

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 §876.5130 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#226 of 1000 · 9,331 reports · 1992–2026

  • BOOK 9,331 reports
  • RANK #226 of 1000
  • DEATH 12 death-typed
  • INJ 1,216 injury-typed
  • MALF 8,048 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,404
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (33 report gap)

Catheter, Retention Type, Balloon sits #226 of 1000 among tracked device types with 9,331 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 run above the device-type norm

Catheter, Retention Type, Balloon carries 86.3% MALFUNCTION-coded reports, 21.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 13.0% corpus 30.3% · below corpus mean (-17.3 pp)
  • MALF 86.3% corpus 64.8% · above corpus mean (+21.4 pp)

Lead product-problem code Deflation Problem is 13% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 54% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Catheter, Retention Type, Balloon in the event-volume neighbourhood

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

reports

What this shows Catheter, Retention Type, Balloon carries 9,331 MAUDE reports, ranked #226 of 1000.

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

Event Types

Malfunction 8,048 (86.3%)
Injury 1,216 (13.0%)
30 (0.3%)
Other 24 (0.3%)
Death 12 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

4,443 (48.1%)
Other 3,881 (42.0%)
Required Intervention 716 (7.7%)
R 63 (0.7%)
Hospitalization 63 (0.7%)
O 27 (0.3%)
H 12 (0.1%)
Death 12 (0.1%)
Disability 7 (0.1%)
Invalid Data 7 (0.1%)
Life Threatening 6 (0.1%)
L 4 (0.0%)
S 2 (0.0%)

Top Product Problems

Deflation Problem 1,027
Burst Container or Vessel 1,017
Material Puncture/Hole 861
Fluid/Blood Leak 816
Difficult to Remove 590
Material Rupture 585
Break 411
Inflation Problem 397
Leak/Splash 350
Material Split, Cut or Torn 258
Material Invagination 251
Decrease in Pressure 238
Device Dislodged or Dislocated 186
Material Fragmentation 171
Adverse Event Without Identified Device or Use Problem 170
Partial Blockage 164
Inaccurate Flow Rate 146
Component Missing 143
Material Deformation 137
Erratic or Intermittent Display 125

Yearly Trend

92
1992: 13
93
1993: 17
94
1994: 23
95
1995: 3
99
1999: 4
00
2000: 1
01
2001: 11
02
2002: 10
03
2003: 5
04
2004: 5
05
2005: 10
06
2006: 10
07
2007: 8
08
2008: 6
09
2009: 6
10
2010: 27
11
2011: 79
12
2012: 65
13
2013: 99
14
2014: 229
15
2015: 303
16
2016: 326
17
2017: 571
18
2018: 677
19
2019: 671
20
2020: 712
21
2021: 702
22
2022: 884
23
2023: 772
24
2024: 1,029
25
2025: 1,404
26
2026: 649

Reports rose to 1,404 in 2025, up from an average of 901 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Retention Type, Balloon

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 3,675
C.R. BARD INC. (COVINGTON) -1018233 1,293
COLOPLAST A/S 1,116
TELEFLEX MEDICAL 571
MEDLINE INDUSTRIES, LP 138

Event Locations

5,423 (58.1%)
I 3,306 (35.4%)
HOSPITAL 423 (4.5%)
NO INFORMATION 118 (1.3%)
OTHER 17 (0.2%)
INVALID DATA 12 (0.1%)
HOME 11 (0.1%)
NURSING HOME 7 (0.1%)
OUTPATIENT TREATMENT FACILITY 7 (0.1%)
UNKNOWN 4 (0.0%)
0 1 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD INC. (COVINGTON) -1018233 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Retention Type, Balloon: 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 (9,331 here).

Prosthesis 9,364 Intervertebral Fusion Device With Bone Graft 9,183 Controller 9,165 Negative Pressure Wound Therapy Powered Suc… 9,164

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Adhesive 12 Digital Breast Tomosynthesis 12 Excimer Laser System 12 Implantable Transprostatic Tissue Retractor… 12

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

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