FLIXENE SLIDER GDS 25061Recalls & reported problems
Atrium Medical Corporation · 6MMX40CM 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862250619), received between Jul 15, 2019 and Nov 15, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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.
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-2004-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Remove1
- Patient Device Interaction Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- Obstruction/Occlusion1
- Thrombosis/Thrombus1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2022, USE FLIXENE 6MM40CM AND EMBED ABOUT 20CM LIKE THE ATTACHED FILE SCHEMA. ON (B)(6) OCCLUSION AND ORGANIC THROMBUS WERE OBSERVED IN THE ELBOW JOINT, AND BLOOD FLOW RESUMED WITH SHUNT MASSAGE. ON (B)(6), AN ATTEMPT WAS MADE TO REMOVE THE REMAINING THROMBUS BY DIRECT SURGERY, AND WHEN A LATERAL INCISION WAS MADE AFTER EXPOSING ABOUT 2 CM OF THE ARTIFICIAL BLOOD VESSEL AT THE ELBOW, THE THREE-LAYER STRUCTURE WAS DISSOCIATED. SINCE THIS PART HAS NEVER BEEN PUNCTURED IN THE PAST, IT IS UNLIKELY THAT THE THREE-LAYER STRUCTURE WILL DISSOCIATE. THE PART THAT CAUSED THE DISSECTION IS THE ELBOW JOINT, WHICH IS NORMAL AND CAN BE FLEXED AND STRETCHED.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Vascular Dissection
MAUDE report 15798596 ↗MalfunctionJul 15, 2019Difficult to Remove
RECEIVED REPORT THAT AFTER VEIN ANASTOMOSIS, WHEN THE SURGEON TRIED TO REMOVE THE VINYL BEFORE ARTERIAL ANASTOMOSIS, IT COULD NOT BE REMOVED WELL AND THE ANASTOMOSIS PART WAS REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER COMPANY'S GRAFT. NO HEALTH DAMAGE TO PATIENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8791284 ↗
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
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 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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