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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#227 of 1000 · 8,858 reports · 1992–2026

  • BOOK 8,858 reports
  • RANK #227 of 1000
  • DEATH 12 death-typed
  • INJ 1,175 injury-typed
  • MALF 7,617 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,392
  • PHOTO Intervertebral Fusion…

Nearest event-volume peer: Intervertebral Fusion Device With Bone Graft, Lumbar (18 report gap)

Catheter, Retention Type, Balloon sits #227 of 1000 among tracked device types with 8,858 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 13.3% corpus 30.4% · below corpus mean (-17.2 pp)
  • MALF 86.0% corpus 64.5% · above corpus mean (+21.5 pp)

Lead product-problem code Burst Container or Vessel is 13% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 58% of manufacturer-tagged reports · Top event location is 56% 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 8,858 MAUDE reports, ranked #227 of 1000.

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

Event Types

Malfunction 7,617 (86.0%)
Injury 1,175 (13.3%)
30 (0.3%)
Other 23 (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.

4,354 (48.7%)
Other 3,689 (41.2%)
Required Intervention 704 (7.9%)
R 62 (0.7%)
Hospitalization 62 (0.7%)
O 24 (0.3%)
Death 12 (0.1%)
H 11 (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

Burst Container or Vessel 910
Deflation Problem 797
Fluid/Blood Leak 756
Material Puncture/Hole 756
Difficult to Remove 515
Material Rupture 491
Break 330
Inflation Problem 310
Leak/Splash 307
Material Split, Cut or Torn 247
Material Invagination 245
Decrease in Pressure 237
Device Dislodged or Dislocated 165
Adverse Event Without Identified Device or Use Problem 163
Material Fragmentation 162
Partial Blockage 148
Inaccurate Flow Rate 133
Component Missing 127
Erratic or Intermittent Display 124
Failure to Infuse 119

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: 1,392
26
2026: 188

Related Entities for Catheter, Retention Type, Balloon

Top Manufacturers

C.R. BARD, INC. (COVINGTON) -1018233 3,680
COLOPLAST A/S 1,068
C.R. BARD INC. (COVINGTON) -1018233 1,022
TELEFLEX MEDICAL 571

Event Locations

4,970 (56.1%)
I 3,306 (37.3%)
HOSPITAL 406 (4.6%)
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 5 (0.1%)
UNKNOWN 4 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs COLOPLAST A/S →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Retention Type, Balloon, 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 (8,858 here).

Intervertebral Fusion Device With Bone Graft 8,876 Controller 8,893 Prosthesis 8,981 Motor, Drill, Pneumatic 8,734

Similar death-typed counts

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

Adhesive 12 Blood Pump For Ecmo, Long-Term Use 12 Digital Breast Tomosynthesis 12 Implant, Dermal, For Aesthetic Use 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.