FLIXENE SLIDER GDS 25128Recalls & reported problems
Atrium Medical Corporation · FLIXENE 4-6MMX35CM 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862251289), received between Aug 24, 2023 and Aug 24, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction 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.
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-2012-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Hypersensitivity/Allergic reaction2
- Post Operative Wound Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
INITIAL REPORT: AFTER THE IMPLANTATION OF A FLIXENE, MASSIVE LOCAL SIGNS OF INFLAMMATION APPEARED WITHIN A SHORT TIME. NO EVIDENCE OF BACTERIAL INFECTION. PROSTHESIS HAD TO BE EXPLANTED AND DISCARDED, PRODUCTS FROM OTHER COMPANIES WERE IMPLANTED WITHOUT PROBLEMS. ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN: PATIENT SUFFERS FROM ACUTE LEUKEMIA THAT CAN NO LONGER BE TREATED. THE INFLAMMATORY STATUS OF THE TISSUE CAN MOST LIKELY BE ATTRIBUTED TO THIS DIAGNOSIS. SUBSEQUENT IMPLANT ALSO BECAME INFLAMED/INFECTED. EVEN AFTER THE PROSTHESIS WAS EXPLANTED, THE WOUND DID NOT HEAL, PUS-FILLED BLISTERS FORMED ALL OVER THE BODY AND ALL PLASTIC DIALYSIS ACCESSES HAD TO BE REMOVED WITHIN A SHORT TIME DUE TO MASSIVE INFECTIONS. THE FAMILY AND THE PATIENT DECIDED ON PALLIATIVE CARE AT HOME AND DIALYSIS WAS DISCONTINUED.
Patient problems: Hypersensitivity/Allergic reaction; Post Operative Wound Infection
MAUDE report 17620776 ↗InjuryAug 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
INITIAL REPORT: AFTER THE IMPLANTATION OF A FLIXENE, MASSIVE LOCAL SIGNS OF INFLAMMATION APPEARED WITHIN A SHORT TIME. NO EVIDENCE OF BACTERIAL INFECTION. PROSTHESIS HAD TO BE EXPLANTED AND DISCARDED, PRODUCTS FROM OTHER COMPANIES WERE IMPLANTED WITHOUT PROBLEMS. ADDITIONAL INFORMATION FROM PHYSICIAN: PATIENT HAD BEEN UNDERGOING DIALYSIS WITH SHUNT. SHUNT FLOW WAS LOW AND SUFFICIENT DIALYSIS WAS DIFFICULT. FLIXENE GRAFT WAS PLACED ON (B)(6) 2023 AS A FOREARM LOOP TO MAINTAIN PUNCTURE DISTANCE. IT WAS TUNNELED DIRECTLY SUBCUTANEOUSLY AS USUAL WITH THE ASSOCIATED TUNNELING SYSTEM AND ANASTOMOSED END-TO-SIDE TO THE PROXIMAL RADIAL ARTERY AND THE ANTEBRACHIAL CEPHALIC VEIN END-TO-END. SWELLING AND REDNESS APPEARED ON THE FIRST POSTOPERATIVE DAY, WITH PAIN AND WARMTH. THE ENTIRE ARM WAS SWOLLEN EVEN THOUGH ONLY THE FOREARM HAD BEEN OPERATED ON. AFTER ABOUT A WEEK A CLASSIC HYPEREMIA DEVELOPED, WHICH COULD BE PUSHED AWAY AND RECURRED, COMPRESSES WITH OCTENISEPT HAD NO EFFECT. CENTRAL STENOSIS WAS RULED OUT. WHEN THE ARM WAS ELASTICALLY WRAPPED AND ELEVATED, THE SWELLING ONLY DECREASED VERY SLOWLY OVER A LONG PERIOD OF TIME, EVEN AFTER THE PROSTHESIS HAD ALREADY BEEN EXPLANTED. THE PAIN D
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 17620772 ↗
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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