2026 data FDA MAUDE openFDA FDA Class II

Sleeve, Limb, Compressible

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 §870.5800 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Sleeve, Limb, Compressible LIGHT-BOOK · MAUDE

#535 of 1000 · 1,705 reports · 1992–2026

  • BOOK 1,705 reports
  • RANK #535 of 1000
  • DEATH 19 death-typed
  • INJ 311 injury-typed
  • MALF 1,167 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 169
  • PHOTO Ear

Nearest event-volume peer: Ear, Nose, And Throat Stereotaxic Instrument (7 report gap)

Sleeve, Limb, Compressible sits #535 of 1000 among tracked device types with 1,705 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 →

Injury-coded reports sit below the device-type norm

Sleeve, Limb, Compressible carries 18.2% INJURY-coded reports, 12.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 18.2% corpus 30.3% · below corpus mean (-12.1 pp)
  • MALF 68.4% corpus 64.8% · above corpus mean (+3.6 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 12% of coded problems · Lead manufacturer COVIDIEN accounts for 95% of manufacturer-tagged reports · Top event location HOSPITAL is 38% of location-tagged rows .

Sleeve, Limb, Compressible in the event-volume neighbourhood

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

reports

What this shows Sleeve, Limb, Compressible carries 1,705 MAUDE reports, ranked #535 of 1000.

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

Event Types

Malfunction 1,167 (68.4%)
Injury 311 (18.2%)
Other 158 (9.3%)
50 (2.9%)
Death 19 (1.1%)

Patient Outcomes

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

1,106 (62.2%)
Other 385 (21.7%)
Required Intervention 112 (6.3%)
Hospitalization 58 (3.3%)
R 42 (2.4%)
Death 19 (1.1%)
S 14 (0.8%)
Disability 11 (0.6%)
Life Threatening 10 (0.6%)
O 8 (0.4%)
L 6 (0.3%)
H 4 (0.2%)
Invalid Data 3 (0.2%)

Top Product Problems

Unknown (for use when the device problem is not known) 175
Break 156
Adverse Event Without Identified Device or Use Problem 150
Scratched Material 105
Thermal Decomposition of Device 104
Electrical /Electronic Property Problem 93
Insufficient Device Problem Information 88
Grounding Malfunction 77
Cut In Material 63
Overheating of Device 58
Sparking 54
Temperature Problem 53
Use of Device Problem 46
Split 42
Device Operates Differently Than Expected 37
Inflation Problem 29
Other (for use when an appropriate device code cannot be identified) 29
Material Frayed 27
Smoking 27
Device Displays Incorrect Message 26

Yearly Trend

92
1992: 5
94
1994: 4
95
1995: 7
96
1996: 9
97
1997: 9
98
1998: 9
99
1999: 16
00
2000: 14
01
2001: 19
02
2002: 14
03
2003: 23
04
2004: 23
05
2005: 32
06
2006: 28
07
2007: 12
08
2008: 36
09
2009: 45
10
2010: 66
11
2011: 50
12
2012: 100
13
2013: 169
14
2014: 93
15
2015: 137
16
2016: 150
17
2017: 149
18
2018: 114
19
2019: 102
20
2020: 50
21
2021: 34
22
2022: 27
23
2023: 57
24
2024: 30
25
2025: 24
26
2026: 48

Reports fell to 24 in 2025, down from an average of 44 in the two years before.

Related Entities for Sleeve, Limb, Compressible

Top Manufacturers

Event Locations

HOSPITAL 652 (38.2%)
I 568 (33.3%)
372 (21.8%)
OTHER 43 (2.5%)
NO INFORMATION 26 (1.5%)
UNKNOWN 15 (0.9%)
AMBULATORY SURGICAL FACILITY 9 (0.5%)
INVALID DATA 9 (0.5%)
OUTPATIENT TREATMENT FACILITY 6 (0.4%)
HOME 4 (0.2%)
NURSING HOME 1 (0.1%)

Compare COVIDIEN vs ZIMMER SURGICAL, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sleeve, Limb, Compressible: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Sleeve, Limb, Compressible 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 Sleeve, Limb, Compressible; 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.