FLIXENE SLIDER GDS 25058Recalls & reported problems
Atrium Medical Corporation · 6MMX50CM FLIXENE GRAFT, GW, W/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
- 13
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00650862250589), received between Jan 31, 2017 and Mar 17, 2026 — classified as 7 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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-2002-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available2
- Complete Blockage2
- Obstruction of Flow2
- Activation, Positioning or Separation Problem1
- Improper or Incorrect Procedure or Method1
- Kinked1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information2
- Blister1
- Embolism1
- Failure to Anastomose1
- Local Reaction1
- Thrombosis/Thrombus1
- Thrombus1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Moisture or Humidity Problem
IT WAS REPORTED THAT FLIXENE GRAFT HAD HUMIDITY LEVELS EXCEEDED 80% FOR MORE THAN 24 HOURS AND REACHED UP TO 100%. DURING INSPECTION, BUBBLING WAS OBSERVED ON THE PRODUCT LABELING, AND ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. THERE WAS NO PATIENT INVOLVED OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619952 ↗MalfunctionNov 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PHYSICIAN DID NOT PERCEIVE THE GRADUATED WALL FEATURE ON THE FLIXENE GRAFT, AS THE WALL THICKNESS DID NOT APPEAR REDUCED TOWARD THE END DURING HANDLING. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580161 ↗MalfunctionNov 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation
(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 19630594 ↗MalfunctionApr 11, 2024Material Separation; Material Separation
DURING THE PROCEDURE THE DOCTOR WAS SUTURING IN FLIXENE GRAFT WHEN HE MENTIONED THAT THE OUTER LAYER OF THE GRAFT HAD APPEARED TO HAVE SEPARATED. HE ALSO COMMENTED THAT THE FLIXENE GRAFT HE IMPLANTED THE WEEK PRIOR ALSO HAD THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088535 ↗MalfunctionAug 29, 2023Material Puncture/Hole; Material Puncture/Hole
GOT A CALL TODAY FROM CUSTOMER AT (B)(6) STATING A FLIXENE GRAFT HAD HOLES IN IT AND LEAKED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17647558 ↗InjuryNov 19, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
InjuryApr 6, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryFeb 17, 2021Complete Blockage; Adverse Event Without Identified Device or Use Problem
InjuryFeb 17, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
InjuryFeb 13, 2021Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 2021Adverse Event Without Identified Device or Use Problem; Complete Blockage; Adverse Event Without Identified Device or Use Problem
APPROXIMATELY 45 DAYS AFTER FLIXENE WAS INSERTED, BLOOD CLOTS WERE FORMED IN THE VEINS OF AUTOGENOUS VASCULAR WHICH CAUSED BLOCKAGE. THE PATIENT RETURNED TO THE EMERGENCY ROOM OF THE HOSPITAL FOR REVASCULARIZATION. THE BLOCKAGE OCCURRED AGAIN SHORTLY AFTER THE REVASCULARIZATION. THUS, THE PATIENT RETURNED TO THE HOSPITAL AGAIN.
Patient problems: Embolism
MAUDE report 11256702 ↗InjuryJan 31, 2017Kinked; Improper or Incorrect Procedure or Method
REPORT RECEIVED STATED THE FLIXENE GRAFT WAS PLACED FOR DIALYSIS IN A PATIENT BUT THE ANASTOMOSIS WAS NOT DONE CORRECTLY. THE GRAFT WAS CUT TOO SHORT AND KINKED. PATIENT WAS GIVEN A CATHETER FOR DIALYSIS.
Patient problems: Failure to Anastomose
MAUDE report 6289951 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 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
- 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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