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AbsorbaTack
Model ABSTACK15 · Covidien LP · DI 10884523006506
GDW — Staple, Implantable · Class II · 21 CFR 878.4750
OCW — Endoscopic Tissue Approximation Device · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-13 · 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 (289)
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: 271 · Injury: 18
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
2
9.09
2019-02
4
8.67
2019-03
4
9.14
2019-04
2
9.71
2019-05
1
8.27
2019-06
1
9.85
2019-07
4
10.06
2019-08
2
8.3
2019-09
1
8.69
2019-10
5
8.48
2019-11
1
8.73
2019-12
5
9.44
2020-01
0
9.16
2020-02
3
8.46
2020-03
2
8.75
2020-04
5
7.62
2020-05
2
6.91
2020-06
1
8.84
2020-07
4
9.47
2020-08
2
8.93
2020-09
2
10.11
2020-10
2
9.94
2020-11
3
9.74
2020-12
3
10.42
2021-01
1
9.01
2021-02
3
8.91
2021-03
3
8.85
2021-04
1
10.1
2021-05
2
9.44
2021-06
4
9.1
2021-07
2
9.03
2021-08
3
11.92
2021-09
1
10.3
2021-10
2
9.83
2021-11
1
8.38
2021-12
1
10.51
2022-01
1
8.84
2022-02
3
8.67
2022-03
2
9.34
2022-04
2
9.22
2022-05
6
9.47
2022-06
3
10.23
2022-07
7
9.31
2022-08
0
10.03
2022-09
1
8.87
2022-10
2
9.66
2022-11
2
9.94
2022-12
1
9.81
2023-01
0
9.1
2023-02
2
9.35
2023-03
5
11.91
2023-04
1
9.2
2023-05
3
9.02
2023-06
3
10.05
2023-07
7
9.97
2023-08
3
8.02
2023-09
6
7.6
2023-10
8
8.31
2023-11
2
7.91
2023-12
5
8.81
2024-01
4
9.15
2024-02
3
9.31
2024-03
2
7.38
2024-04
2
8.38
2024-05
0
6.88
2024-06
3
8.04
2024-07
2
8.06
2024-08
5
7.1
2024-09
4
9.47
2024-10
2
8.16
2024-11
5
9.42
2024-12
3
7.08
2025-01
5
8.53
2025-02
7
7.17
2025-03
2
7.01
2025-04
7
6.68
2025-05
7
8.68
2025-06
1
7.88
2025-07
7
10.29
2025-08
2
8.41
2025-09
4
8.36
2025-10
3
7.85
2025-11
3
8.37
2025-12
6
9.84
2026-01
7
8.94
2026-02
7
8.66
2026-03
4
9.11
2026-04
9
8.99
2026-05
5
8.2
2026-06
8
9.93
This device (reports/month)Average device in GDW, OCW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Covidien LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2012-06-14 Covidien, LP
Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.