FLIXENE SLIDER GDS 25138Recalls & reported problems
Atrium Medical Corporation · FLIXENE 4-7MMX45CM 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
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00650862251388), received between Jan 31, 2017 and Sep 11, 2026 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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. 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-2017-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow4
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Material Too Rigid or Stiff1
- No Apparent Adverse Event1
Patient problems
- Occlusion3
- Bacterial Infection1
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Reaction1
Recent adverse event reports
The 7 most recent of 7 reports, 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 ↗InjuryFeb 17, 2026Obstruction of Flow
InjuryMay 29, 2020Material Too Rigid or Stiff; Obstruction 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 NOT LONGER POSSIBLE.
Patient problems: Occlusion
MAUDE report 10103695 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT.
Patient problems: Occlusion
MAUDE report 10103690 ↗InjuryMay 29, 2020Obstruction of Flow
IT WAS REPORTED THAT A PATIENT EXPERIENCED A EARLY GRAFT OCCLUSION AFTER IMPLANT.
Patient problems: Occlusion
MAUDE report 10103686 ↗InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem
REPORT RECEIVED STATED PATIENT WAS EXHIBITING SEVERE REDNESS AND INFLAMMATION AT GRAFT IMPLANTATION SITE. FLIXENE GRAFT WAS EXPLANTED FROM PATIENT.
Patient problems: Inflammation; Reaction
MAUDE report 9777728 ↗MalfunctionJan 31, 2017Device-Device Incompatibility
REPORT RECEIVED FROM THE PHYSICIAN STATED THAT THE 4MM END OF THE 4-7 FLIXENE GRAFT IS LARGER THEN 4MM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6289927 ↗
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
- 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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