ADVANTA SLIDER GDS 22064Recalls & reported problems
Atrium Medical Corporation · 8MMX50CM, SW, H, ADVANTA VXT, GDS · Class 2 · Implant
All models of ADVANTA SLIDER GDS (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00650862220643), received between Nov 21, 2016 and Jun 27, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 3, 2024Open, Classified
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1967-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected3
- Fluid/Blood Leak1
- Material Separation1
Patient problems
- No Information2
- No Known Impact Or Consequence To Patient2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING IMPLANTATION OF ADVANTA VXT GRAFT IT STARTED BLEEDING THROUGH THE GRAFT WALL AND NOT ONLY SUTURE HOLES. THIS HAPPENED AFTER PART OF THE SUPPORT HELIX WAS REMOVED. TO STOP THE HEAVY BLEEDING SURGEON USED 2 X TISSEEL TISSUE GLUE TO GET THE BLEEDING UNDER CONTROL. THIS LED TO A PROLONGED SURGERY. THERE WAS NO REPORTED ADVERSE EFFECTS TO THE PATIENT POST SURGERY AND THE GRAFT REMAINS IMPLANTED IN THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22345559 ↗MalfunctionMar 27, 2017Material Separation
REPORT RECEIVED STATED THAT DURING ANASTOMOSIS, WHILE ATTEMPTING TO REMOVE THE HELIX FROM THE GRAFT THE SECOND LAYER WAS LIFTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6436867 ↗MalfunctionMar 27, 2017Device Operates Differently Than Expected
REPORT RECEIVED STATED THAT DURING ANASTOMOSIS, WHILE ATTEMPTING TO REMOVE THE HELIX FROM THE GRAFT THE SECOND LAYER WAS LIFTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6436821 ↗MalfunctionNov 21, 2016Device Operates Differently Than Expected
REPORT RECEIVED STATED THAT THE SECOND LAYER OF THE GRAFT WAS LIFTING DURING THE REMOVAL OF THE HELIX.
Patient problems: No Information
MAUDE report 6119502 ↗MalfunctionNov 21, 2016Device Operates Differently Than Expected
REPORT RECEIVED STATED THAT THE SECOND LAYER OF THE GRAFT WAS LIFTING DURING THE REMOVAL OF THE HELIX.
Patient problems: No Information
MAUDE report 6119496 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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