ADVANTA SLIDER GDS 22012Recalls & reported problems
Atrium Medical Corporation · 6MMX40CM, SW, ADVANTA VXT, GDS · Class 2 · Implant
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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00650862220124), received between Sep 25, 2019 and Apr 24, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (4 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. 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-1952-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Material Separation4
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Material Separation; Material Separation
DURING A TUNNELING PROCEDURE, THE GDS SEPARATED AFTER TUNNELING AND COMBINING, IT JUST FALLS OUT WHEN PULLED OUT. IT WAS REMOVED AND REPLACED WITH NEW PRODUCT. NO PATIENT HARM, ONLY FIVE MINUTE DELAY TO REPLACE GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19172910 ↗MalfunctionApr 24, 2024Material Separation; Material Separation
DURING A PROCEDURE, THE GDS JUST FALLS OUT WHEN COMBINED AFTER TUNNELING AND PULLED OUT. NO PATIENT INJURY OR HARM BUT THE PATIENT FELT SOME PAIN AND PRESSED THE AREA FOR ABOUT 5 MINUTES. SURGICAL DELAY OF TEN MINUTES TO REPLACE GRAFT.
Patient problems: Pain
MAUDE report 19172781 ↗MalfunctionMar 5, 2024Material Separation; Material Separation
MalfunctionJan 29, 2024Material Separation; Material Separation
MalfunctionSep 25, 2019Detachment of Device or Device Component
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.