FLIXENE SLIDER GDSRecalls & reported problems across all models
Atrium Medical Corporation · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
17 open recalls name at least one FLIXENE SLIDER GDS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 17
We found 17 models of FLIXENE SLIDER GDS by Atrium Medical Corporation in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2017 and Sep 11, 2026 — classified as 30 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (14 reports).
17 FDA recall records name at least one of these models by its device identifier, 17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
FLIXENE SLIDER GDS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-2018-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2017-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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 ↗
- 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-2015-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2014-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2013-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2012-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2011-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2010-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2009-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2008-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2007-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2006-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2005-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2004-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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-2003-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
- 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 FLIXENE SLIDER GDS problems
Device problems
- Obstruction of Flow14
- Adverse Event Without Identified Device or Use Problem8
- Material Separation4
- Complete Blockage3
- Moisture or Humidity Problem3
- Patient Device Interaction Problem3
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Occlusion9
- Insufficient Information4
- Hematoma3
- No Known Impact Or Consequence To Patient3
- Thrombosis/Thrombus3
- Hemorrhage/Blood Loss/Bleeding2
- Hypersensitivity/Allergic reaction2
FLIXENE SLIDER GDS models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FLIXENE SLIDER GDS 25058PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- FLIXENE SLIDER GDS 25129PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- FLIXENE SLIDER GDS 25137PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
- FLIXENE SLIDER GDS 25135PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall3 reports
- FLIXENE SLIDER GDS 25142PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall3 reports
- FLIXENE SLIDER GDS 25061PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall2 reports
- FLIXENE SLIDER GDS 25126PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall2 reports
- FLIXENE SLIDER GDS 25128PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall2 reports
- FLIXENE SLIDER GDS 25141PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall2 reports
- FLIXENE SLIDER GDS 25052PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall1 report
- FLIXENE SLIDER GDS 25056PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- FLIXENE SLIDER GDS 25059PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- FLIXENE SLIDER GDS 25062PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- FLIXENE SLIDER GDS 25120PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- FLIXENE SLIDER GDS 25125PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- FLIXENE SLIDER GDS 25134PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
Recent FLIXENE SLIDER GDS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2026No Apparent Adverse Event
It was reported that the patient with an implanted Flixene graft tested positive for Pseudomonas aeruginosa infection on (b)(6) 2026. The graft was explanted during surgical revision.
Patient problems: Bacterial Infection
MAUDE report 50737153 ↗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 ↗MalfunctionMar 18, 2026Moisture or Humidity Problem
MalfunctionMar 18, 2026Moisture or Humidity Problem
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 ↗InjuryMar 17, 2026Obstruction of Flow
InjuryMar 9, 2026Obstruction of Flow
InjuryFeb 17, 2026Obstruction of Flow
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
MalfunctionAug 7, 2025Material Integrity Problem; Material Integrity Problem
MalfunctionJul 9, 2025Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow
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
(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 ↗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 ↗
Other Atrium Medical Corporation products
All Atrium Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page