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ADVANTA
Model 21000 · Atrium Medical Corporation · DI 00650862210002
DSY — Prosthesis, Vascular Graft, Of 6mm And Greater 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 (39)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2024-05-03 | Z-1992-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1990-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1991-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1952-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1953-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1955-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1956-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1957-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1959-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1960-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1961-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1963-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1965-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1966-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1967-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1968-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1969-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1970-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1971-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1972-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1973-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1974-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1975-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1976-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1977-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1978-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1979-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1980-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1981-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1982-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1983-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1984-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1985-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1986-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1987-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1988-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2024-05-03 | Z-1989-2024 | Class II | Open, Classified | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. | k number procode |
| 2021-08-25 | Z-2589-2021 | Class II | Terminated | The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. | k number procode |
| 2013-07-12 | Z-2304-2013 | Class II | Terminated | Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field | k number procode |
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.43 |
| 2019-02 | 0 | 3.17 |
| 2019-03 | 0 | 2.38 |
| 2019-04 | 0 | 2.71 |
| 2019-05 | 0 | 2.2 |
| 2019-06 | 0 | 1.83 |
| 2019-07 | 0 | 2.06 |
| 2019-08 | 0 | 5.89 |
| 2019-09 | 0 | 2.27 |
| 2019-10 | 0 | 3.87 |
| 2019-11 | 0 | 3.75 |
| 2019-12 | 0 | 3.25 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 2.17 |
| 2020-03 | 0 | 3.43 |
| 2020-04 | 0 | 2.43 |
| 2020-05 | 0 | 4.29 |
| 2020-06 | 0 | 3 |
| 2020-07 | 0 | 2.67 |
| 2020-08 | 0 | 2.13 |
| 2020-09 | 0 | 2.25 |
| 2020-10 | 0 | 2.67 |
| 2020-11 | 0 | 2.69 |
| 2020-12 | 0 | 2.54 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 2.67 |
| 2021-03 | 0 | 2.13 |
| 2021-04 | 0 | 2.09 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 3.23 |
| 2021-07 | 0 | 4.67 |
| 2021-08 | 0 | 1.83 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 2.67 |
| 2021-11 | 0 | 2.13 |
| 2021-12 | 0 | 3.11 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 2.8 |
| 2022-03 | 0 | 4.14 |
| 2022-04 | 0 | 2.7 |
| 2022-05 | 0 | 2.5 |
| 2022-06 | 0 | 4.5 |
| 2022-07 | 0 | 1.88 |
| 2022-08 | 0 | 2.86 |
| 2022-09 | 0 | 2.4 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 4 |
| 2022-12 | 0 | 4 |
| 2023-01 | 0 | 2.5 |
| 2023-02 | 0 | 3.29 |
| 2023-03 | 0 | 4.5 |
| 2023-04 | 0 | 3.83 |
| 2023-05 | 0 | 3.5 |
| 2023-06 | 0 | 3.4 |
| 2023-07 | 0 | 4.36 |
| 2023-08 | 0 | 2.79 |
| 2023-09 | 0 | 3 |
| 2023-10 | 0 | 2.25 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 2.4 |
| 2024-01 | 0 | 5 |
| 2024-02 | 0 | 4.43 |
| 2024-03 | 0 | 2.38 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 2.17 |
| 2024-06 | 0 | 4 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 1.83 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 1.5 |
| 2024-12 | 0 | 2.14 |
| 2025-01 | 0 | 2.36 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 2.5 |
| 2025-05 | 0 | 3.71 |
| 2025-06 | 0 | 1.78 |
| 2025-07 | 0 | 4.57 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 3 |
| 2025-11 | 0 | 2.75 |
| 2025-12 | 0 | 2.5 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 3.35 |
| 2026-04 | 0 | 7.33 |
| 2026-05 | 0 | 3.44 |
| 2026-06 | 0 | 4.2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K231972 — cites (transitively): K071923 (d1), K992958 (d1), K992960 (d1)
K992960 — cited as predicate by K231972
Lineage extracted from public 510(k) summary text (heuristic).
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