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ACHIEVE
Model BA1411 · CAREFUSION 2200, INC · DI 10885403238062
GDF — Guide, Needle, Surgical · Class I · 21 CFR 878.4800
KNW — Instrument, Biopsy · Class II · 21 CFR 876.1075
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 (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
10.56
2019-02
0
4.13
2019-03
0
2.6
2019-04
0
3.5
2019-05
0
7.38
2019-06
0
38.93
2019-07
0
8.98
2019-08
0
59.4
2019-09
0
30.31
2019-10
0
10.54
2019-11
0
33.61
2019-12
0
44.74
2020-01
0
39.04
2020-02
0
31.54
2020-03
0
137.06
2020-04
0
60.42
2020-05
0
33.55
2020-06
0
63.42
2020-07
0
57.25
2020-08
0
33.63
2020-09
0
40.24
2020-10
0
21.3
2020-11
0
28.13
2020-12
0
15.74
2021-01
0
19.26
2021-02
0
12.97
2021-03
0
12.7
2021-04
0
8.46
2021-05
0
4.29
2021-06
0
4.73
2021-07
0
5.77
2021-08
0
6.36
2021-09
0
10.65
2021-10
0
5.2
2021-11
0
4.17
2021-12
0
7.29
2022-01
0
6.9
2022-02
0
8.39
2022-03
0
5.48
2022-04
0
3.76
2022-05
0
3
2022-06
0
2.68
2022-07
0
3.74
2022-08
0
3.95
2022-09
0
5.42
2022-10
0
5.82
2022-11
0
3.89
2022-12
0
5.74
2023-01
0
3.73
2023-02
0
6.29
2023-03
0
5.15
2023-04
0
6.26
2023-05
0
5.15
2023-06
0
5.86
2023-07
0
4.85
2023-08
0
5.52
2023-09
0
4.63
2023-10
0
8.55
2023-11
0
6.86
2023-12
0
7.35
2024-01
0
9.97
2024-02
0
5.05
2024-03
0
4.14
2024-04
0
7.54
2024-05
0
5.44
2024-06
0
11.44
2024-07
0
6.11
2024-08
0
9.62
2024-09
0
13.25
2024-10
0
6.5
2024-11
0
4.24
2024-12
0
5.88
2025-01
0
4.57
2025-02
0
6.53
2025-03
0
11.14
2025-04
0
8.25
2025-05
0
8.45
2025-06
0
6.73
2025-07
0
6.06
2025-08
0
11.61
2025-09
0
6.9
2025-10
0
5.76
2025-11
0
8.29
2025-12
0
8.87
2026-01
0
15.38
2026-02
0
16.34
2026-03
0
10.95
2026-04
0
15.03
2026-05
0
15.42
2026-06
0
23.48
This device (reports/month)Average device in GDF, KNW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — CAREFUSION 2200, INC