Atrium Medical
FDA adverse event reports naming Atrium Medical as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ATRIUM MEDICAL.
- Total reports
- 1,673
- Deaths
- 57
- Injuries
- 1,483
- Malfunctions
- 130
Reports per year
Source: FDA adverse event reports by year received, 1993–2019. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, PolymericFTL1,280
- Stent, IliacNIO77
- Stent, RenalNIN75
- Prosthesis, Tracheal, ExpandableJCT68
- Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY59
- Apparatus, AutotransfusionCAC50
- Bottle, Collection, VacuumKDQ37
- Catheter, CholangiographyGBZ21
- Prosthesis, Vascular Graft, Of Less Then 6mm DiameterDYF2
- Tube, Drainage, SuprapubicFFA2
Recent recalls
- 2024-10-07Open, ClassifiedUnder Investigation by firm
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- 2024-06-04Open, ClassifiedEquipment maintenance
ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
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