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Bard® DeBakey® Woven Polyester Fabric
Model 007956 · Bard Peripheral Vascular, Inc. · DI 00801741041266
DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · Class II · 21 CFR 870.3470
UDILibrary device dossier · generated 2026-09-15 · 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 (0)
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.
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
1
2019-02
0
2
2019-03
0
3
2019-04
0
1.33
2019-05
0
1
2019-06
0
1
2019-07
0
3
2019-08
0
1.38
2019-10
0
2
2019-11
0
2.86
2019-12
0
2
2020-02
0
1
2020-04
0
3
2020-06
0
1.5
2020-07
0
1.5
2020-09
0
1
2020-10
0
2
2020-11
0
3.22
2020-12
0
4.5
2021-01
0
1
2021-02
0
2
2021-03
0
3
2021-05
0
36
2021-06
0
1
2021-07
0
2
2021-09
0
3
2021-11
0
2
2021-12
0
1.67
2022-01
0
1
2022-04
0
4
2022-05
0
2
2022-06
0
20
2022-07
0
2.5
2022-10
0
3
2022-11
0
6.33
2022-12
0
3
2023-01
0
2.67
2023-02
0
3
2023-03
0
12
2023-04
0
6.5
2023-05
0
12
2023-06
0
3
2023-07
0
1
2023-11
0
4.5
2023-12
0
2
2024-03
0
2
2024-04
0
1
2024-06
0
4
2024-08
0
10
2024-09
0
1
2024-10
0
27
2024-11
0
3
2024-12
0
1
2025-01
0
2
2025-05
0
1
2025-09
0
2
2025-10
0
6.67
2025-11
0
30.5
2026-03
0
1.5
2026-04
0
2
2026-06
0
2
This device (reports/month)Average device in DXZ (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