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ACCESSORIES
Model 22295 · ABBOTT VASCULAR INC. · DI 08717648013331
DQX — Wire, Guide, Catheter · Class II · 21 CFR 870.1330
UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2011-01-07
Z-2791-2011
Terminated
Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
k number procode
Adverse-event reports — MAUDE (25)
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: 17 · Injury: 8
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
1.64
2019-02
0
1.52
2019-03
0
1.78
2019-04
0
1.69
2019-05
0
1.69
2019-06
0
1.57
2019-07
0
2.02
2019-08
0
2.38
2019-09
0
2.08
2019-10
0
2.24
2019-11
0
2.03
2019-12
0
2.52
2020-01
0
2.3
2020-02
0
2.95
2020-03
0
2.85
2020-04
0
2.16
2020-05
0
2.68
2020-06
0
2.49
2020-07
0
2.84
2020-08
0
2.54
2020-09
0
2.44
2020-10
0
2.65
2020-11
0
2.68
2020-12
0
2.75
2021-01
0
3.03
2021-02
0
2.16
2021-03
0
2.69
2021-04
0
2.62
2021-05
0
2.05
2021-06
0
2.42
2021-07
0
3.07
2021-08
0
2.39
2021-09
0
2.41
2021-10
0
2.02
2021-11
0
2.34
2021-12
0
2.64
2022-01
0
2.63
2022-02
0
2.35
2022-03
0
2.36
2022-04
0
2.61
2022-05
0
2.86
2022-06
0
2.75
2022-07
0
2.57
2022-08
0
3.01
2022-09
0
2.56
2022-10
0
2.26
2022-11
0
2.62
2022-12
0
2.42
2023-01
0
1.86
2023-02
0
2.64
2023-03
0
2.56
2023-04
3
2.25
2023-05
0
2.99
2023-06
0
2.39
2023-07
0
2.63
2023-08
0
2.65
2023-09
0
2.76
2023-10
0
2.54
2023-11
0
2.64
2023-12
2
2.8
2024-01
0
2.65
2024-02
0
2.63
2024-03
0
2.81
2024-04
0
2.26
2024-05
0
3.29
2024-06
0
3.05
2024-07
0
2.31
2024-08
0
3.62
2024-09
3
3.04
2024-10
0
4.01
2024-11
0
3.37
2024-12
0
3.81
2025-01
8
2.98
2025-02
0
3.19
2025-03
0
3.22
2025-04
0
3.49
2025-05
0
3.33
2025-06
0
2.89
2025-07
0
3.12
2025-08
0
3.21
2025-09
0
3.5
2025-10
0
3.24
2025-11
0
3.94
2025-12
0
4.49
2026-01
3
3.58
2026-02
0
3.79
2026-03
0
3.9
2026-04
0
2.99
2026-05
6
2.69
2026-06
0
2.84
This device (reports/month)Average device in DQX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ABBOTT VASCULAR INC.
NAI 2023-12-08 Abbott Vascular · 0 citations
OAI 2023-11-16 Abbott Vascular · 0 citations
NAI 2023-10-27 Abbott Vascular Inc · 0 citations
NAI 2022-08-23 Abbott Vascular Inc · 0 citations
NAI 2021-11-03 Abbott Vascular Inc · 0 citations
NAI 2019-10-24 Abbott Vascular · 0 citations
VAI 2017-11-15 Abbott Vascular · 2 citations
NAI 2017-10-10 Abbott Vascular · 0 citations
NAI 2017-10-04 Abbott Vascular Inc · 0 citations
NAI 2016-12-09 Abbott Vascular · 0 citations
NAI 2016-04-15 Abbott Vascular Inc · 0 citations
NAI 2015-12-10 Abbott Vascular · 0 citations
NAI 2015-09-11 Abbott Vascular · 0 citations
NAI 2015-08-14 Abbott Vascular, Inc. · 0 citations