FLIXENE SLIDER GDS 25129Recalls & reported problems
Atrium Medical Corporation · FLIXENE 4-7MMX35CM GWT-GW, W/DBL GDS · Class 2 · Implant
All models of FLIXENE SLIDER GDS (17)
Data updated Oct 18, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00650862251296), received between Jul 3, 2019 and May 3, 2026 — classified as 6 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (6 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 18, 2026.
Reports received per month
Recalls naming this device
- May 3, 2024Class IIOpen, 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-2013-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow6
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Material Separation1
- Peeled/Delaminated1
Patient problems
- Occlusion4
- No Clinical Signs, Symptoms or Conditions3
- Hematoma1
- Swelling1
- Thrombosis/Thrombus1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT PRIOR TO IMPLANTING THE FLIXENE GRAFT, THE PHYSICIAN OBSERVED THAT SALINE WAS WEEPING EXCESSIVELY THROUGH THE GRAFT WALL WHILE FLUSHING. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062634 ↗MalfunctionJul 9, 2025Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow
InjuryApr 30, 2023Obstruction of Flow; Obstruction of Flow
MalfunctionJan 18, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE SURGEON CUT FLIXENE GRAFT WITH A SCALPEL TO PREPARE FOR SUTURING. AFTER CUTTING THE GRAFT IT DELAMINATED APPROXIMATELY 1CM, THE OUTER LAYER OF GRAFT PEELED BACK ON ITSELF. PHYSICIAN THEN CUT GRAFT AGAIN WITH NO ISSUE AND CASE WAS COMPLETED. THERE WAS NO INJURY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13285973 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT. THE GRAFTS WERE STRONG AND STIFF AFTER A WHILE AND EASY PUNCTURE NO LONGER POSSIBLE.
Patient problems: Occlusion
MAUDE report 10103696 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT.
Patient problems: Occlusion
MAUDE report 10103694 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT. GRAFT BECAME STIFF AND STRONG AFTER A WHILE AND EASY PUNCTURE WAS NOT LONGER POSSIBLE.
Patient problems: Occlusion
MAUDE report 10103693 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT. PUNCTURE AFTER A WHILE NOT LONGER EASILY POSSIBLE, GRAFTS BECOMES STIFF AND STRONG.
Patient problems: Occlusion
MAUDE report 10103691 ↗InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem
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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium 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
- Cardioroot HEWROOT0028Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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