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Skater™ Introducer System

Model 651506300 · ARGON MEDICAL DEVICES, INC. · DI 00886333004515

GCB — Needle, Catheter · Class I · 21 CFR 878.4200

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 (30)

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: 27 · Injury: 3

13462019-02: 0 reports for this device; peer average 3/device2019-08: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2020-01: 1 reports for this device; peer average 1.5/device2020-02: 1 reports for this device; peer average 1/device2020-03: 4 reports for this device; peer average 3/device2020-04: 2 reports for this device; peer average 1.5/device2020-05: 2 reports for this device; peer average 2/device2020-06: 3 reports for this device; peer average 3/device2020-07: 3 reports for this device; peer average 3/device2020-09: 1 reports for this device; peer average 5.5/device2020-10: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2/device2021-04: 1 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3.5/device2021-08: 0 reports for this device; peer average 1/device2021-10: 2 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 2.2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 3 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2/device2023-04: 3 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-08: 2 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2/device2024-06: 2 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 3/device2025-01: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 5/device2026-01: 0 reports for this device; peer average 1/device020810111201020304050607091012020304060708101103040608091011010304050608101101050611120103040506071101
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0203
2019-0802
2019-1001
2019-1103
2019-1202
2020-0111.5
2020-0211
2020-0343
2020-0421.5
2020-0522
2020-0633
2020-0733
2020-0915.5
2020-1002
2020-1202
2021-0202
2021-0302
2021-0411
2021-0602
2021-0703.5
2021-0801
2021-1022.33
2021-1101
2022-0301
2022-0403
2022-0602
2022-0802.2
2022-0901
2022-1033
2022-1101
2023-0102
2023-0302
2023-0432
2023-0501
2023-0601
2023-0822
2023-1001
2023-1102
2024-0101
2024-0502
2024-0622
2024-1101
2024-1203
2025-0103
2025-0301
2025-0401.5
2025-0501
2025-0601
2025-0701
2025-1105
2026-0101
This device (reports/month)Average device in GCB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ARGON MEDICAL DEVICES, INC.

  • Warning Letter 2014-07-03 Argon Medical Devices, Inc
  • Warning Letter 2014-07-03 Argon Medical Devices, Inc
  • NAI 2021-11-04 Argon Medical Devices, Inc · 0 citations
  • NAI 2021-11-04 Argon Medical Devices, Inc · 0 citations
  • VAI 2016-05-27 Argon Medical Devices, Inc · 2 citations
  • VAI 2016-05-27 Argon Medical Devices, Inc · 2 citations
  • NAI 2016-05-04 Argon Medical Devices Inc. · 0 citations
  • NAI 2016-05-04 Argon Medical Devices Inc. · 0 citations
  • VAI 2013-12-13 Argon Medical Devices, Inc · 3 citations
  • VAI 2013-12-13 Argon Medical Devices, Inc · 3 citations
  • VAI 2012-01-18 Argon Medical Devices Inc. · 3 citations
  • VAI 2012-01-18 Argon Medical Devices Inc. · 3 citations
  • VAI 2011-05-18 Argon Medical Devices, Inc · 1 citations
  • VAI 2011-05-18 Argon Medical Devices, Inc · 1 citations