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2026 data FDA MAUDE openFDA FDA Class II

Pump, Portable, Aspiration (Manual Or Powered)

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 §878.4780 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Pump, Portable, Aspiration LIGHT-BOOK · MAUDE

#675 of 1000 · 968 reports · 1992–2026

  • BOOK 968 reports
  • RANK #675 of 1000
  • DEATH 29 death-typed
  • INJ 69 injury-typed
  • MALF 753 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 399
  • PHOTO Blade, Scalpel

Nearest event-volume peer: Blade, Scalpel (2 report gap)

Pump, Portable, Aspiration (Manual Or Powered) sits #675 of 1000 among tracked device types with 968 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

Pump, Portable, Aspiration carries 7.1% INJURY-coded reports, 23.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 7.1% corpus 30.3% · below corpus mean (-23.2 pp)
  • MALF 77.8% corpus 64.8% · above corpus mean (+13.0 pp)

Lead product-problem code Device Alarm System is 29% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 86% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Pump, Portable, Aspiration in the event-volume neighbourhood

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

reports

What this shows Pump, Portable, Aspiration (Manual Or Powered) carries 968 MAUDE reports, ranked #675 of 1000.

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

Event Types

Malfunction 753 (77.8%)
Other 89 (9.2%)
Injury 69 (7.1%)
Death 29 (3.0%)
28 (2.9%)

Patient Outcomes

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

488 (48.9%)
Other 406 (40.7%)
Death 34 (3.4%)
Required Intervention 18 (1.8%)
Hospitalization 14 (1.4%)
O 13 (1.3%)
R 13 (1.3%)
Life Threatening 5 (0.5%)
L 4 (0.4%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Device Alarm System 301
Leak/Splash 88
Suction Problem 84
Device Operates Differently Than Expected 73
Crack 65
Break 50
Device Inoperable 48
Fluid/Blood Leak 40
Defective Component 36
Sticking 28
Thermal Decomposition of Device 28
Disconnection 26
Electrical /Electronic Property Problem 24
Detachment Of Device Component 22
Adverse Event Without Identified Device or Use Problem 21
Battery Problem 21
Improper or Incorrect Procedure or Method 21
Decrease in Suction 20
Repair 20
Device Emits Odor 18

Yearly Trend

92
1992: 4
94
1994: 3
97
1997: 2
98
1998: 6
99
1999: 7
00
2000: 6
01
2001: 11
02
2002: 8
03
2003: 6
04
2004: 5
05
2005: 10
06
2006: 14
07
2007: 13
08
2008: 5
09
2009: 14
10
2010: 178
11
2011: 62
12
2012: 47
13
2013: 18
14
2014: 399
15
2015: 15
16
2016: 25
17
2017: 4
18
2018: 17
19
2019: 14
20
2020: 10
21
2021: 9
22
2022: 7
23
2023: 8
24
2024: 13
25
2025: 13
26
2026: 15

Reports in 2025 (13) held close to the prior two-year average of 11.

Related Entities for Pump, Portable, Aspiration (Manual Or Powered)

Top Manufacturers

PENUMBRA, INC. 175
PENUMBRA INC. 28

Event Locations

549 (56.7%)
HOSPITAL 308 (31.8%)
I 65 (6.7%)
OTHER 13 (1.3%)
HOME 12 (1.2%)
NO INFORMATION 6 (0.6%)
NOT APPLICABLE 4 (0.4%)
OUTPATIENT TREATMENT FACILITY 3 (0.3%)
UNKNOWN 3 (0.3%)
INVALID DATA 2 (0.2%)
NURSING HOME 2 (0.2%)
CLINIC - WALK IN, OTHER 1 (0.1%)

Compare PENUMBRA, INC. vs PENUMBRA INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pump, Portable, Aspiration: 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 (968 here).

Blade, Scalpel 970 Alarm, Conditioned Response Enuresis 965 Percutaneously Delivered Prostheses And Tri… 965 Recorder, Magnetic Tape, Medical 962

Similar death-typed counts

Nearest other device types by death-typed report count (29 here), distinct from the volume row.

Catheter, Urological 29 Integrated Continuous Glucose Monitoring Sy… 29 Apparatus, Nitric Oxide Delivery 30 Appliance 28

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

Disclaimer: MAUDE figures for Pump, Portable, Aspiration 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 Pump, Portable, Aspiration; 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.