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2026 data FDA MAUDE openFDA FDA Class II

Extractor, Vacuum, Fetal

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 §884.4340 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Extractor, Vacuum, Fetal LIGHT-BOOK · MAUDE

#760 of 1000 · 751 reports · 1993–2026

  • BOOK 751 reports
  • RANK #760 of 1000
  • DEATH 111 death-typed
  • INJ 333 injury-typed
  • MALF 226 malfunction
  • SPAN 1993–2026
  • PEAK 1998: 88
  • PHOTO Catheter, Balloon Type

Nearest event-volume peer: Catheter, Balloon Type (0 report gap)

Extractor, Vacuum, Fetal sits #760 of 1000 among tracked device types with 751 MAUDE reports spanning 1993–2026. 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

Extractor, Vacuum, Fetal carries 30.1% MALFUNCTION-coded reports, 34.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 14.8% corpus 1.5% · above corpus mean (+13.3 pp)
  • INJ 44.3% corpus 30.3% · above corpus mean (+14.0 pp)
  • MALF 30.1% corpus 64.8% · below corpus mean (-34.7 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 34% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Extractor, Vacuum, Fetal in the event-volume neighbourhood

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

reports

What this shows Extractor, Vacuum, Fetal carries 751 MAUDE reports, ranked #760 of 1000.

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

Event Types

Injury 333 (44.3%)
Malfunction 226 (30.1%)
Death 111 (14.8%)
Other 57 (7.6%)
24 (3.2%)

Patient Outcomes

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

210 (23.9%)
Other 177 (20.2%)
Hospitalization 137 (15.6%)
Death 99 (11.3%)
Required Intervention 91 (10.4%)
R 50 (5.7%)
L 33 (3.8%)
Life Threatening 23 (2.6%)
O 18 (2.1%)
S 16 (1.8%)
H 10 (1.1%)
Disability 10 (1.1%)
Congenital Anomaly 4 (0.5%)

Top Product Problems

Unknown (for use when the device problem is not known) 235
Other (for use when an appropriate device code cannot be identified) 69
Break 55
Insufficient Device Problem Information 47
Use of Device Problem 45
Suction Problem 40
Device Operates Differently Than Expected 30
Material Separation 19
Difficult to Remove 18
Decrease in Suction 16
Reaction 16
Device Issue 15
Detachment Of Device Component 14
Sticking 14
Suction Failure 14
Adverse Event Without Identified Device or Use Problem 12
Detachment of Device or Device Component 11
Replace 10
Appropriate Device Problem Term/Code Not Available 8
Dislodged 8

Yearly Trend

93
1993: 1
94
1994: 5
95
1995: 5
96
1996: 11
97
1997: 17
98
1998: 88
99
1999: 62
00
2000: 60
01
2001: 25
02
2002: 23
03
2003: 21
04
2004: 19
05
2005: 29
06
2006: 19
07
2007: 25
08
2008: 35
09
2009: 12
10
2010: 13
11
2011: 8
12
2012: 9
13
2013: 7
14
2014: 11
15
2015: 13
16
2016: 15
17
2017: 16
18
2018: 25
19
2019: 31
20
2020: 24
21
2021: 21
22
2022: 12
23
2023: 23
24
2024: 24
25
2025: 17
26
2026: 25

Reports in 2025 (17) held close to the prior two-year average of 24.

Related Entities for Extractor, Vacuum, Fetal

Top Manufacturers

UNK 33

Event Locations

330 (43.9%)
HOSPITAL 320 (42.6%)
I 58 (7.7%)
NO INFORMATION 15 (2.0%)
INVALID DATA 14 (1.9%)
UNKNOWN 10 (1.3%)
HOME 2 (0.3%)
OTHER 2 (0.3%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Extractor, Vacuum, Fetal: 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).

Catheter, Balloon Type 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 (111 here), distinct from the volume row.

Absorbable Coronary Drug-Eluting Stent 110 Gas-Machine, Anesthesia 112 Temporary Carotid Catheter For Embolic Capt… 112 Prosthesis, Tracheal, Expandable 108

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

Disclaimer: MAUDE figures for Extractor, Vacuum, Fetal 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 Extractor, Vacuum, Fetal; 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.