ADVANTA SLIDER GDS 22225Recalls & reported problems
Atrium Medical Corporation · 6MMX80CM, TW, H, ADVANTA VXT, GDS · Class 2 · Implant
Data updated Oct 13, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862222258), received between Feb 1, 2017 and Jun 6, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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. How this data works · Data updated Oct 13, 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-1989-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Material Integrity Problem1
- Peeled/Delaminated1
Patient problems
- Implant Pain1
- Intraoperative Pain1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH ADVANTA VXT GDS GRAFT NEEDED A SURGICAL REVISION AS THE PROSTHESIS STARTED TO TEAR ABOVE THE DISTAL ANASTOMOSIS HOWEVER THE DEVICE WAS NOT EXPLANTED BUT PATCHED. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: Implant Pain; Intraoperative Pain
MAUDE report 22158265 ↗MalfunctionFeb 1, 2017Peeled/Delaminated; Device Operates Differently Than Expected
REPORT RECEIVED STATED THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE HELIX OF THE GRAFT THE SECOND LAYER OF THE GRAFT ALSO PEELED OFF.
Patient problems: No Information
MAUDE report 6294386 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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