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072 Aspiration System

Model FG 01252 · Q'APEL MEDICAL LLC · DI 00857545008127

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

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)

InitiatedRecall #ClassStatusReasonLink basis
2025-02-26Z-1512-2025Class IOpen, ClassifiedAspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.code info di

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.

13462019-01: 0 reports for this device; peer average 2.64/device2019-02: 0 reports for this device; peer average 3.27/device2019-03: 0 reports for this device; peer average 2.21/device2019-04: 0 reports for this device; peer average 2.4/device2019-05: 0 reports for this device; peer average 2.18/device2019-06: 0 reports for this device; peer average 3.28/device2019-07: 0 reports for this device; peer average 3.95/device2019-08: 0 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 2.53/device2019-10: 0 reports for this device; peer average 3.61/device2019-11: 0 reports for this device; peer average 3.11/device2019-12: 0 reports for this device; peer average 3.55/device2020-01: 0 reports for this device; peer average 3.91/device2020-02: 0 reports for this device; peer average 5.88/device2020-03: 0 reports for this device; peer average 3.63/device2020-04: 0 reports for this device; peer average 3.42/device2020-05: 0 reports for this device; peer average 4.13/device2020-06: 0 reports for this device; peer average 3.5/device2020-07: 0 reports for this device; peer average 3.28/device2020-08: 0 reports for this device; peer average 3.71/device2020-09: 0 reports for this device; peer average 3.21/device2020-10: 0 reports for this device; peer average 3.89/device2020-11: 0 reports for this device; peer average 4.39/device2020-12: 0 reports for this device; peer average 4.48/device2021-01: 0 reports for this device; peer average 3.62/device2021-02: 0 reports for this device; peer average 3.65/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 3.29/device2021-05: 0 reports for this device; peer average 3.35/device2021-06: 0 reports for this device; peer average 2.53/device2021-07: 0 reports for this device; peer average 2.68/device2021-08: 0 reports for this device; peer average 3.19/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4.62/device2021-12: 0 reports for this device; peer average 4.36/device2022-01: 0 reports for this device; peer average 4.08/device2022-02: 0 reports for this device; peer average 5.7/device2022-03: 0 reports for this device; peer average 4.5/device2022-04: 0 reports for this device; peer average 2.69/device2022-05: 0 reports for this device; peer average 2.38/device2022-06: 0 reports for this device; peer average 3.81/device2022-07: 0 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 1.84/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.67/device2022-11: 0 reports for this device; peer average 1.77/device2022-12: 0 reports for this device; peer average 3.07/device2023-01: 0 reports for this device; peer average 2.73/device2023-02: 0 reports for this device; peer average 2.82/device2023-03: 0 reports for this device; peer average 2.85/device2023-04: 0 reports for this device; peer average 2.62/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 3.52/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 3.3/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 3.17/device2023-11: 0 reports for this device; peer average 3.07/device2023-12: 0 reports for this device; peer average 2.79/device2024-01: 0 reports for this device; peer average 2.65/device2024-02: 0 reports for this device; peer average 3.08/device2024-03: 0 reports for this device; peer average 2.45/device2024-04: 0 reports for this device; peer average 3.24/device2024-05: 0 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 1.73/device2024-07: 0 reports for this device; peer average 2.53/device2024-08: 0 reports for this device; peer average 3.2/device2024-09: 0 reports for this device; peer average 2.36/device2024-10: 0 reports for this device; peer average 2.81/device2024-11: 0 reports for this device; peer average 2.44/device2024-12: 0 reports for this device; peer average 2.55/device2025-01: 0 reports for this device; peer average 1.89/device2025-02: 0 reports for this device; peer average 2.82/device2025-03: 0 reports for this device; peer average 1.65/device2025-04: 0 reports for this device; peer average 3.24/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2.68/device2025-07: 0 reports for this device; peer average 2.21/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.88/device2025-10: 0 reports for this device; peer average 2.43/device2025-11: 0 reports for this device; peer average 1.6/device2025-12: 0 reports for this device; peer average 2.35/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.76/device2026-04: 0 reports for this device; peer average 4.18/device2026-05: 0 reports for this device; peer average 3.5/device2026-06: 0 reports for this device; peer average 2.58/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.64
2019-0203.27
2019-0302.21
2019-0402.4
2019-0502.18
2019-0603.28
2019-0703.95
2019-0803.9
2019-0902.53
2019-1003.61
2019-1103.11
2019-1203.55
2020-0103.91
2020-0205.88
2020-0303.63
2020-0403.42
2020-0504.13
2020-0603.5
2020-0703.28
2020-0803.71
2020-0903.21
2020-1003.89
2020-1104.39
2020-1204.48
2021-0103.62
2021-0203.65
2021-0303
2021-0403.29
2021-0503.35
2021-0602.53
2021-0702.68
2021-0803.19
2021-0904
2021-1004
2021-1104.62
2021-1204.36
2022-0104.08
2022-0205.7
2022-0304.5
2022-0402.69
2022-0502.38
2022-0603.81
2022-0703.17
2022-0801.84
2022-0902.82
2022-1003.67
2022-1101.77
2022-1203.07
2023-0102.73
2023-0202.82
2023-0302.85
2023-0402.62
2023-0502.88
2023-0603.52
2023-0702.31
2023-0803.3
2023-0902.5
2023-1003.17
2023-1103.07
2023-1202.79
2024-0102.65
2024-0203.08
2024-0302.45
2024-0403.24
2024-0502.7
2024-0601.73
2024-0702.53
2024-0803.2
2024-0902.36
2024-1002.81
2024-1102.44
2024-1202.55
2025-0101.89
2025-0202.82
2025-0301.65
2025-0403.24
2025-0502
2025-0602.68
2025-0702.21
2025-0801.5
2025-0901.88
2025-1002.43
2025-1101.6
2025-1202.35
2026-0101.94
2026-0202
2026-0301.76
2026-0404.18
2026-0503.5
2026-0602.58
This device (reports/month)Average device in NRY (reports/device/month)

Regulatory clearances

  • K222786 SESE 2023-08-25 (k number procode)

Predicate lineage

K222786 — cites (transitively): K191946 (d1), K193380 (d1), K211564 (d1), K211654 (d1), K083125 (d2), K173761 (d2), K190010 (d2), K161064 (d2), K191237 (d2), K033247 (d2), K052633 (d2), K062168 (d2), K062449 (d2), K071378 (d2), K073592 (d2), K091734 (d2), K092896 (d2), K112086 (d2), K133189 (d2), K152361 (d2), K182273 (d2), K192657 (d2), K822536 (d2), K912944 (d2), K924116 (d2), K934086 (d2), K935668 (d2), K944875 (d2), K963071 (d2), K991557 (d2), K042784 (d3), K984088 (d3), K860204 (d3), K050456 (d3), K071691 (d3), K063503 (d3), K152541 (d3), K161640 (d3), K162901 (d3), K173773 (d3), K183463 (d3), K151960 (d3), K023183 (d4), K072696 (d4), K073178 (d4), K903390 (d4), K993782 (d4), K142458 (d4), K160449 (d4), K153071 (d4), K063090 (d4), K082905 (d4), K151667 (d4), K180715 (d4), K072718 (d5), K090752 (d5), K100769 (d5), K113163 (d5), K133317 (d5), K090335 (d5), K110483 (d5), K114083 (d5), K133177 (d5), K113455 (d5), K123378 (d5), K141491 (d5), K051758 (d5), K122756 (d5), K151623 (d5), K110055 (d5), K070970 (d6), K080583 (d6), K063774 (d6), K081305 (d6), K082034 (d6), K090085 (d6)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Q'APEL MEDICAL LLC

  • Warning Letter 2025-02-05 Q'apel Medical, Inc.
  • OAI 2024-08-08 Qapel Medical Inc. · 7 citations
  • VAI 2022-03-08 Q'apel Medical, Inc. · 2 citations