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DENALI® Vena Cava Filter
Model DL900J · Bard Peripheral Vascular, Inc. · DI 00801741040795
DTK — Filter, Intravascular, Cardiovascular · Class II · 21 CFR 870.3375
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 (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (1082)
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: 685 · Injury: 349 · Death: 48
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
6
6.5
2019-02
1
4.38
2019-03
6
8.1
2019-04
32
10.93
2019-05
3
6.82
2019-06
12
7.85
2019-07
48
11.53
2019-08
17
9.71
2019-09
28
14.71
2019-10
49
11.63
2019-11
27
9.77
2019-12
10
9.6
2020-01
69
17.29
2020-02
11
14.6
2020-03
9
9.91
2020-04
25
14.76
2020-05
7
5.29
2020-06
11
7.86
2020-07
45
19.07
2020-08
12
7.11
2020-09
6
7
2020-10
61
26.67
2020-11
31
9.5
2020-12
24
8.95
2021-01
31
11.38
2021-02
15
18.95
2021-03
58
11.24
2021-04
37
9.75
2021-05
15
8
2021-06
12
14.19
2021-07
33
11.14
2021-08
9
8.06
2021-09
9
7.27
2021-10
40
6.26
2021-11
6
9.09
2021-12
4
8.44
2022-01
9
5.14
2022-02
9
4.74
2022-03
18
4.86
2022-04
24
6
2022-05
11
11.64
2022-06
3
4.77
2022-07
9
4.36
2022-08
3
4.7
2022-09
3
4
2022-10
2
3.17
2022-11
3
1.83
2022-12
11
4.44
2023-01
6
3.69
2023-02
6
3.4
2023-03
9
3.6
2023-04
0
2.83
2023-05
3
4
2023-06
3
7.22
2023-07
6
3.8
2023-08
6
3
2023-09
4
2.08
2023-10
4
3.78
2023-11
3
2.67
2023-12
10
4.78
2024-01
2
1.6
2024-02
8
3.2
2024-03
8
3.5
2024-04
6
3.57
2024-05
2
2.5
2024-06
8
4.17
2024-07
0
2.4
2024-08
0
3.14
2024-09
4
3
2024-10
4
2.83
2024-11
4
2.38
2024-12
1
4.4
2025-01
0
1.5
2025-02
0
1.57
2025-03
0
3.6
2025-04
2
1.57
2025-05
4
4.33
2025-06
4
4.2
2025-07
0
3.14
2025-08
0
2.75
2025-09
0
3.57
2025-10
4
3.8
2025-11
10
3.6
2025-12
0
2.83
2026-01
4
3.5
2026-02
6
4.2
2026-03
11
6.2
2026-04
4
2.25
2026-05
0
3.33
2026-06
2
2.25
This device (reports/month)Average device in DTK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Bard Peripheral Vascular, Inc.
NAI 2026-04-21 Bard Peripheral Vascular Inc · 0 citations
NAI 2024-03-08 Bard Peripheral Vascular Inc · 0 citations
NAI 2018-11-02 Bard Peripheral Vascular Inc · 0 citations
NAI 2017-02-03 Bard Peripheral Vascular Inc · 0 citations
NAI 2016-11-01 Bard Peripheral Vascular Inc · 0 citations
VAI 2016-02-26 Bard Peripheral Vascular Inc · 2 citations
VAI 2015-12-18 Bard Peripheral Vascular Inc · 0 citations