FLIXENE SLIDER GDS 25137Recalls & reported problems
Atrium Medical Corporation · FLIXENE 4-6MMX45CM GWT-GW, W/DBL GDS · Class 2 · Implant
All models of FLIXENE SLIDER GDS (17)
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
- 8
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862251371), received between Dec 21, 2018 and Mar 18, 2026 — classified as 3 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Moisture or Humidity Problem” (2 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-2016-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Moisture or Humidity Problem2
- Complete Blockage1
- Device Damaged by Another Device1
- Material Disintegration1
- Material Fragmentation1
- Material Integrity Problem1
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Occlusion2
- Aneurysm1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Moisture or Humidity Problem
MalfunctionMar 18, 2026Moisture or Humidity Problem
MalfunctionJun 26, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT UPON OPENING THE FLIXENE GRAFT THE CUSTOMER EXPERIENCED AN UNUSUAL HARDNESS COMPARED TO PREVIOUSLY USED PRODUCTS. THE SURGEON DID NOT FEEL COMFORTABLE USING THE DEVICE SO HE SWITCHED THE DEVICE TO A STRAIGHT 6MM GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341497 ↗MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation
DR. (B)(6) REPORTED THAT HE HAD EXPERIENCED SEVERAL CASES WHERE THE VASCULAR MARKINGS HAD DISAPPEARED AND THE OUTER WALL HAD GOTTEN PEELED OFF AFTER IMPLANTING A FLIXENE VASCULAR GRAFT USING A SHEATH-TYPE TUNNELER. (IT WAS CONFIRMED THAT THERE WERE NO PROBLEMS BEFORE TUNNELING.) AT PRESENT, THERE HAVE BEEN NO PROBLEMS AFTER SURGERY, AND THE PROGRESS IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19630576 ↗InjuryAug 22, 2021Material Disintegration; Material Integrity Problem; Material Integrity Problem
REPORT RECEIVED STATED THAT A FLIXENE GRAFT THAT WAS PLACED APPROXIMATELY 12 MONTHS AGO IN CONJUNCTION WITH A HERO GRAFT WAS EXPLANTED. THE PHYSICIAN BELIEVES THE GRAFT HAS DISINTEGRATED. ADDITIONAL INFORMATION RECEIVED STATED THE FLIXENE GRAFT WAS REMOVED DUE TO FALSE ANEURYSMS FORMING ALONG THE GRAFT.
Patient problems: Aneurysm
MAUDE report 12352032 ↗MalfunctionMay 4, 2021Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem
InjuryOct 22, 2019Complete Blockage
IT WAS REPORTED THAT TWO DAYS AFTER IMPLANT THE GRAFT BECAME OCCLUDED. THE GRAFT HAD TO BE EXPLANTED 3 WEEKS AFTER IMPLANT.
Patient problems: Occlusion
MAUDE report 9219651 ↗InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS IMPLANTED THE FLIXENE (SHORT-TAPERED) DEVELOPED VASCULAR OCCLUSION AND HAS BEEN RECEIVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY REPEATEDLY. THE FIRST VASCULAR OCCLUSION OCCURRED AT THE ANASTOMOSIS AREA ON THE ARTERIAL SIDE, AND THEN, ALSO OCCURRED AT THE ANASTOMOSIS AREA ON THE VENOUS SIDE. THIS IS THE FIRST AVG FOR THE PATIENT.
Patient problems: Occlusion
MAUDE report 8192389 ↗
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
- 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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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