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Aquilex® Fluid Control System
Model AQL-100CBS · W.O.M. World of Medicine GmbH · DI 04056702006556
HIG — Insufflator, Hysteroscopic · Class II · 21 CFR 884.1700
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2023-07-17
Z-2629-2023
Class II
Open, Classified
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
k number procode
2019-08-14
Z-2767-2019
Class II
Terminated
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
code info di
Adverse-event reports — MAUDE (32)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 28 · Injury: 4
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-02
0
4
2019-03
0
3
2019-04
0
6.5
2019-05
0
2.33
2019-06
4
4.25
2019-07
2
2
2019-08
1
2
2019-09
6
4
2019-10
4
2.4
2019-11
0
2
2019-12
0
1.8
2020-01
0
1.5
2020-02
2
1.5
2020-03
0
2.33
2020-04
0
2
2020-05
0
1.33
2020-07
0
2
2020-08
0
1.67
2020-09
0
1.5
2020-10
0
2.2
2020-11
0
1
2020-12
0
2
2021-02
0
7
2021-03
0
6.67
2021-04
5
3
2021-05
0
2.5
2021-06
0
12.25
2021-07
0
22.5
2021-08
0
16.5
2021-09
0
8.5
2021-10
0
30
2021-11
0
22
2021-12
0
11.75
2022-01
0
12.67
2022-02
0
9
2022-03
0
34
2022-04
0
3.25
2022-05
0
3
2022-06
0
1.67
2022-07
0
3
2022-08
0
2
2022-09
0
4
2022-10
0
2
2022-11
0
2
2022-12
2
2
2023-02
0
2.67
2023-03
0
3
2023-04
0
2
2023-05
0
2.33
2023-06
4
2.5
2023-07
0
3
2023-08
0
1.67
2023-09
0
2.75
2023-10
0
2
2023-11
0
3
2023-12
0
2.33
2024-01
0
3.5
2024-02
0
3.5
2024-03
0
2
2024-04
0
3.25
2024-05
0
2
2024-06
0
2.33
2024-07
0
3.5
2024-08
0
1.67
2024-09
0
1.5
2024-10
0
5
2024-11
0
6.67
2024-12
0
4
2025-01
0
1.6
2025-02
0
3.5
2025-03
0
3
2025-04
0
1
2025-05
0
3
2025-06
0
1.8
2025-07
0
5
2025-09
0
1.5
2025-10
2
2.83
2025-11
0
3
2025-12
0
2
2026-01
0
2
2026-02
0
2.5
2026-03
0
3.2
2026-04
0
2
2026-05
0
1.25
2026-06
0
3.83
This device (reports/month)Average device in HIG (reports/device/month)