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ReactTM

Model REACT-68 · Micro Therapeutics, Inc. · DI 00847536031777

DQY — Catheter, Percutaneous · Class II · 21 CFR 870.1250

NRY — Catheter, Thrombus Retriever · Class II · 21 CFR 870.1250

UDILibrary device dossier · generated 2026-09-12 · 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 (10)

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: 7 · Injury: 2 · Death: 1

12342019-01: 2 reports for this device; peer average 2.61/device2019-02: 1 reports for this device; peer average 2.09/device2019-03: 0 reports for this device; peer average 1.88/device2019-04: 0 reports for this device; peer average 2.37/device2019-05: 1 reports for this device; peer average 1.84/device2019-06: 0 reports for this device; peer average 2.09/device2019-07: 0 reports for this device; peer average 2.66/device2019-08: 0 reports for this device; peer average 2.26/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 2.8/device2019-11: 0 reports for this device; peer average 2.11/device2019-12: 0 reports for this device; peer average 2.24/device2020-01: 0 reports for this device; peer average 2.98/device2020-02: 0 reports for this device; peer average 2.51/device2020-03: 1 reports for this device; peer average 2.36/device2020-04: 0 reports for this device; peer average 2.7/device2020-05: 0 reports for this device; peer average 2.4/device2020-06: 0 reports for this device; peer average 2.44/device2020-07: 0 reports for this device; peer average 3.17/device2020-08: 0 reports for this device; peer average 2.44/device2020-09: 1 reports for this device; peer average 2.46/device2020-10: 0 reports for this device; peer average 3.19/device2020-11: 0 reports for this device; peer average 2.57/device2020-12: 0 reports for this device; peer average 2.83/device2021-01: 0 reports for this device; peer average 2.7/device2021-02: 0 reports for this device; peer average 2.66/device2021-03: 0 reports for this device; peer average 2.47/device2021-04: 0 reports for this device; peer average 2.32/device2021-05: 0 reports for this device; peer average 2.83/device2021-06: 0 reports for this device; peer average 2.46/device2021-07: 0 reports for this device; peer average 2.26/device2021-08: 0 reports for this device; peer average 2.57/device2021-09: 0 reports for this device; peer average 2.39/device2021-10: 0 reports for this device; peer average 2.48/device2021-11: 0 reports for this device; peer average 2.39/device2021-12: 0 reports for this device; peer average 2.48/device2022-01: 0 reports for this device; peer average 2.36/device2022-02: 0 reports for this device; peer average 2.44/device2022-03: 0 reports for this device; peer average 2.2/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 1.91/device2022-06: 1 reports for this device; peer average 2.42/device2022-07: 0 reports for this device; peer average 2.15/device2022-08: 1 reports for this device; peer average 2.29/device2022-09: 0 reports for this device; peer average 2.28/device2022-10: 1 reports for this device; peer average 2.41/device2022-11: 1 reports for this device; peer average 2.04/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 1.91/device2023-02: 0 reports for this device; peer average 2.11/device2023-03: 0 reports for this device; peer average 2.11/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 0 reports for this device; peer average 2.01/device2023-06: 0 reports for this device; peer average 2.34/device2023-07: 0 reports for this device; peer average 2.08/device2023-08: 0 reports for this device; peer average 2.06/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2.37/device2023-11: 0 reports for this device; peer average 2.52/device2023-12: 0 reports for this device; peer average 2.48/device2024-01: 0 reports for this device; peer average 1.93/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 2.09/device2024-05: 0 reports for this device; peer average 2.04/device2024-06: 0 reports for this device; peer average 2.04/device2024-07: 0 reports for this device; peer average 2.08/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 2.1/device2024-10: 0 reports for this device; peer average 2.35/device2024-11: 0 reports for this device; peer average 2.42/device2024-12: 0 reports for this device; peer average 2.91/device2025-01: 0 reports for this device; peer average 2.75/device2025-02: 0 reports for this device; peer average 2.86/device2025-03: 0 reports for this device; peer average 2.53/device2025-04: 0 reports for this device; peer average 2.57/device2025-05: 0 reports for this device; peer average 2.57/device2025-06: 0 reports for this device; peer average 3.15/device2025-07: 0 reports for this device; peer average 3.09/device2025-08: 0 reports for this device; peer average 2.53/device2025-09: 0 reports for this device; peer average 2.77/device2025-10: 0 reports for this device; peer average 3.2/device2025-11: 0 reports for this device; peer average 2.99/device2025-12: 0 reports for this device; peer average 3.65/device2026-01: 0 reports for this device; peer average 3.28/device2026-02: 0 reports for this device; peer average 3.16/device2026-03: 0 reports for this device; peer average 3.1/device2026-04: 0 reports for this device; peer average 3.14/device2026-05: 0 reports for this device; peer average 3.42/device2026-06: 0 reports for this device; peer average 3.31/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0122.61
2019-0212.09
2019-0301.88
2019-0402.37
2019-0511.84
2019-0602.09
2019-0702.66
2019-0802.26
2019-0901.79
2019-1002.8
2019-1102.11
2019-1202.24
2020-0102.98
2020-0202.51
2020-0312.36
2020-0402.7
2020-0502.4
2020-0602.44
2020-0703.17
2020-0802.44
2020-0912.46
2020-1003.19
2020-1102.57
2020-1202.83
2021-0102.7
2021-0202.66
2021-0302.47
2021-0402.32
2021-0502.83
2021-0602.46
2021-0702.26
2021-0802.57
2021-0902.39
2021-1002.48
2021-1102.39
2021-1202.48
2022-0102.36
2022-0202.44
2022-0302.2
2022-0402.3
2022-0501.91
2022-0612.42
2022-0702.15
2022-0812.29
2022-0902.28
2022-1012.41
2022-1112.04
2022-1202.04
2023-0101.91
2023-0202.11
2023-0302.11
2023-0402.22
2023-0502.01
2023-0602.34
2023-0702.08
2023-0802.06
2023-0902
2023-1002.37
2023-1102.52
2023-1202.48
2024-0101.93
2024-0202.14
2024-0301.91
2024-0402.09
2024-0502.04
2024-0602.04
2024-0702.08
2024-0802.14
2024-0902.1
2024-1002.35
2024-1102.42
2024-1202.91
2025-0102.75
2025-0202.86
2025-0302.53
2025-0402.57
2025-0502.57
2025-0603.15
2025-0703.09
2025-0802.53
2025-0902.77
2025-1003.2
2025-1102.99
2025-1203.65
2026-0103.28
2026-0203.16
2026-0303.1
2026-0403.14
2026-0503.42
2026-0603.31
This device (reports/month)Average device in DQY, NRY (reports/device/month)

Regulatory clearances

  • K180705 SESE 2018-07-04 (k number procode)

Predicate lineage

K180705 — cites (transitively): K150107 (d1), K161064 (d1), K172448 (d1), K110055 (d2), K152541 (d2), K090752 (d2), K122756 (d2), K133317 (d2), K160449 (d2), K070970 (d3), K072718 (d3), K142458 (d3), K051758 (d3), K100769 (d3), K113163 (d3), K151623 (d3) — cited as predicate by K182101, K220716

K180715 — cites (transitively): K110055 (d1), K151667 (d1), K070970 (d2), K090335 (d2), K110483 (d2), K114083 (d2), K133177 (d2), K080583 (d3) — cited as predicate by K182097, K183463, K193548, K201690, K210230, K220716, K241177

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