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Solitaire 2
Model SFR2-6-20 · Micro Therapeutics, Inc. · DI 00836462016392
NRY — Catheter, Thrombus Retriever · Class II · 21 CFR 870.1250
POL — Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment · Class II · 21 CFR 882.5600
UDILibrary device dossier · generated 2026-09-07 · 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
2.53
2019-02
0
3.27
2019-03
0
2.09
2019-04
0
2.09
2019-05
0
1.93
2019-06
0
3.16
2019-07
0
3.57
2019-08
0
3.9
2019-09
0
2.26
2019-10
0
3.61
2019-11
0
2.81
2019-12
0
3.19
2020-01
0
3.58
2020-02
0
5
2020-03
0
3.35
2020-04
0
3.14
2020-05
0
3.43
2020-06
0
3.31
2020-07
0
3
2020-08
0
3.14
2020-09
0
3
2020-10
0
3.42
2020-11
0
4.24
2020-12
0
4.11
2021-01
0
3.27
2021-02
0
3.19
2021-03
0
2.81
2021-04
0
3.16
2021-05
0
3.12
2021-06
0
2.38
2021-07
0
2.54
2021-08
0
2.94
2021-09
0
3.6
2021-10
0
4
2021-11
0
4.39
2021-12
0
4.36
2022-01
0
3.86
2022-02
0
4.77
2022-03
0
4.2
2022-04
0
2.5
2022-05
0
2.22
2022-06
0
3.81
2022-07
0
3
2022-08
0
1.77
2022-09
0
2.68
2022-10
0
3.4
2022-11
0
1.75
2022-12
0
2.81
2023-01
0
2.59
2023-02
0
2.6
2023-03
0
2.61
2023-04
0
2.45
2023-05
0
2.61
2023-06
0
3.33
2023-07
0
2.11
2023-08
0
2.96
2023-09
0
2.32
2023-10
0
2.96
2023-11
0
2.94
2023-12
0
2.74
2024-01
0
2.8
2024-02
0
2.93
2024-03
0
2.23
2024-04
0
3.48
2024-05
0
2.73
2024-06
0
1.61
2024-07
0
2.42
2024-08
0
3
2024-09
0
2.36
2024-10
0
2.73
2024-11
0
2.38
2024-12
0
2.35
2025-01
0
1.81
2025-02
0
2.63
2025-03
0
1.57
2025-04
0
3.11
2025-05
0
1.92
2025-06
0
2.54
2025-07
0
2.14
2025-08
0
1.42
2025-09
0
1.83
2025-10
0
2.43
2025-11
0
1.56
2025-12
0
2.21
2026-01
0
1.89
2026-02
0
1.95
2026-03
0
1.67
2026-04
0
4.18
2026-05
0
3.25
2026-06
0
2.46
This device (reports/month)Average device in NRY, POL (reports/device/month)
Regulatory clearances
K123378 SESE 2012-11-30 (k number procode)
Predicate lineage
K123378 — cited as predicate by K141491, K153071, K162539
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Micro Therapeutics, Inc.
VAI 2021-09-17 Micro Therapeutics, Inc. · 0 citations
VAI 2015-07-17 Micro Therapeutics, Inc. · 1 citations
NAI 2015-03-26 Micro Therapeutics, Inc. · 0 citations
NAI 2013-03-27 Micro Therapeutics, Inc. · 0 citations
NAI 2012-01-09 Micro Therapeutics, Inc. · 0 citations