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ADVANTA SLIDER GDS

Model 22117 · Atrium Medical Corporation · DI 00650862221176

DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Class II · 21 CFR 870.3450

DWS — Instruments, Surgical, Cardiovascular · Class I · 21 CFR 870.4500

DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · Class II · 21 CFR 870.3450

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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2024-05-03Z-1996-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.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.

12452019-01: 0 reports for this device; peer average 2.56/device2019-02: 0 reports for this device; peer average 3.14/device2019-03: 0 reports for this device; peer average 2.33/device2019-04: 0 reports for this device; peer average 2.5/device2019-05: 0 reports for this device; peer average 2.08/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.1/device2019-08: 0 reports for this device; peer average 4.57/device2019-09: 0 reports for this device; peer average 2.07/device2019-10: 0 reports for this device; peer average 3.33/device2019-11: 0 reports for this device; peer average 3.2/device2019-12: 0 reports for this device; peer average 3.1/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 2.6/device2020-05: 0 reports for this device; peer average 3.9/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.83/device2020-08: 0 reports for this device; peer average 2.11/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2.52/device2020-11: 0 reports for this device; peer average 2.72/device2020-12: 0 reports for this device; peer average 2.58/device2021-01: 0 reports for this device; peer average 2.09/device2021-02: 0 reports for this device; peer average 2.63/device2021-03: 0 reports for this device; peer average 2.17/device2021-04: 0 reports for this device; peer average 2.59/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 3.11/device2021-07: 0 reports for this device; peer average 3.5/device2021-08: 0 reports for this device; peer average 1.56/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2.75/device2021-11: 0 reports for this device; peer average 1.94/device2021-12: 0 reports for this device; peer average 2.86/device2022-01: 0 reports for this device; peer average 1.71/device2022-02: 0 reports for this device; peer average 2.7/device2022-03: 0 reports for this device; peer average 3.67/device2022-04: 0 reports for this device; peer average 2.59/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 4.13/device2022-07: 0 reports for this device; peer average 1.88/device2022-08: 0 reports for this device; peer average 3.36/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 2.29/device2022-11: 0 reports for this device; peer average 3.36/device2022-12: 0 reports for this device; peer average 3.14/device2023-01: 0 reports for this device; peer average 1.6/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 4.2/device2023-04: 0 reports for this device; peer average 4.1/device2023-05: 0 reports for this device; peer average 3.75/device2023-06: 0 reports for this device; peer average 3.29/device2023-07: 0 reports for this device; peer average 4.57/device2023-08: 0 reports for this device; peer average 2.41/device2023-09: 0 reports for this device; peer average 2.75/device2023-10: 0 reports for this device; peer average 2.18/device2023-11: 0 reports for this device; peer average 1.57/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 3.5/device2024-02: 0 reports for this device; peer average 3.63/device2024-03: 0 reports for this device; peer average 3.24/device2024-04: 0 reports for this device; peer average 1.86/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 3.9/device2024-07: 0 reports for this device; peer average 2.09/device2024-08: 0 reports for this device; peer average 2.33/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 1.46/device2024-12: 0 reports for this device; peer average 2.1/device2025-01: 0 reports for this device; peer average 2.27/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 3.5/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 4.25/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.14/device2025-10: 0 reports for this device; peer average 2.89/device2025-11: 0 reports for this device; peer average 2.6/device2025-12: 0 reports for this device; peer average 2.75/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 3.07/device2026-04: 0 reports for this device; peer average 4.88/device2026-05: 0 reports for this device; peer average 3.03/device2026-06: 0 reports for this device; peer average 4/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.56
2019-0203.14
2019-0302.33
2019-0402.5
2019-0502.08
2019-0602
2019-0702.1
2019-0804.57
2019-0902.07
2019-1003.33
2019-1103.2
2019-1203.1
2020-0103
2020-0202.18
2020-0303
2020-0402.6
2020-0503.9
2020-0603
2020-0702.83
2020-0802.11
2020-0902
2020-1002.52
2020-1102.72
2020-1202.58
2021-0102.09
2021-0202.63
2021-0302.17
2021-0402.59
2021-0502
2021-0603.11
2021-0703.5
2021-0801.56
2021-0902
2021-1002.75
2021-1101.94
2021-1202.86
2022-0101.71
2022-0202.7
2022-0303.67
2022-0402.59
2022-0502.5
2022-0604.13
2022-0701.88
2022-0803.36
2022-0902.29
2022-1002.29
2022-1103.36
2022-1203.14
2023-0101.6
2023-0203
2023-0304.2
2023-0404.1
2023-0503.75
2023-0603.29
2023-0704.57
2023-0802.41
2023-0902.75
2023-1002.18
2023-1101.57
2023-1202.33
2024-0103.5
2024-0203.63
2024-0303.24
2024-0401.86
2024-0501.5
2024-0603.9
2024-0702.09
2024-0802.33
2024-0902
2024-1001.83
2024-1101.46
2024-1202.1
2025-0102.27
2025-0201
2025-0301.88
2025-0402
2025-0503.5
2025-0601.87
2025-0704.25
2025-0802
2025-0901.14
2025-1002.89
2025-1102.6
2025-1202.75
2026-0102
2026-0201.8
2026-0303.07
2026-0404.88
2026-0503.03
2026-0604
This device (reports/month)Average device in DSY, DWS, DYF (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Atrium Medical Corporation

  • Warning Letter 2012-10-11 Atrium Medical Corporation
  • Warning Letter 2012-10-11 Atrium Medical Corporation
  • VAI 2024-11-26 Atrium Medical Corporation · 8 citations
  • VAI 2024-11-26 Atrium Medical Corporation · 8 citations
  • VAI 2022-09-06 Atrium Medical Corporation · 0 citations
  • VAI 2022-09-06 Atrium Medical Corporation · 0 citations
  • OAI 2020-02-10 Atrium Medical Corporation · 0 citations
  • OAI 2020-02-10 Atrium Medical Corporation · 0 citations
  • NAI 2018-08-02 Atrium Medical Corporation · 0 citations
  • NAI 2018-08-02 Atrium Medical Corporation · 0 citations
  • OAI 2016-07-13 Atrium Medical Corporation · 0 citations
  • OAI 2016-07-13 Atrium Medical Corporation · 0 citations
  • NAI 2016-01-08 Atrium Medical Corporation · 0 citations
  • NAI 2016-01-08 Atrium Medical Corporation · 0 citations
  • OAI 2013-10-01 Atrium Medical Corporation · 8 citations
  • OAI 2013-10-01 Atrium Medical Corporation · 8 citations
  • OAI 2012-09-07 Atrium Medical Corporation · 5 citations
  • OAI 2012-09-07 Atrium Medical Corporation · 5 citations
  • VAI 2010-03-15 Atrium Medical Corporation · 0 citations
  • VAI 2010-03-15 Atrium Medical Corporation · 0 citations