Food, drugs, devices › Atrium Medical Corporation
Device recall: Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for art
Atrium Medical Corporation (Hudson, NH) initiated this device recall on 12 Jul 2013; FDA lists 14 product records under event 65697, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 15 Jul 2014. Initiation: voluntary: firm initiated. Atrium Medical Corporation has 29 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Atrium Medical Corporation, Hudson, NH.
Reason for recall
"Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field"
Distribution
"Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2304-2013 | Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2305-2013 | Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2306-2013 | Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2307-2013 | Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2308-2013 | Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2309-2013 | Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2310-2013 | Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2311-2013 | Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2312-2013 | Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2313-2013 | Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2314-2013 | Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2315-2013 | Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2316-2013 | Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
| Z-2317-2013 | Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | — | Class II | Terminated | 9 Oct 2013 |
Context
Other enforcement events for Atrium Medical Corporation
All 29 events for Atrium Medical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.