ADVANTA SLIDER GDS 22185Recalls & reported problems
Atrium Medical Corporation · 6MMX70CM, TW, ADVANTA VXT, GDS · Class 2 · Implant
All models of ADVANTA SLIDER GDS (51)
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 00650862221855), received between May 25, 2026 and Aug 31, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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-1977-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow2
Patient problems
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Obstruction of Flow
As part of Post-Market Clinical Follow-up (PMCF) Registry for VXT and Flixene Grafts the following adverse event information was provided regarding a VXT graft.The patient underwent a CT scan that revealed occlusion of the lower limb arteries. Treatment was initiated with a femoroperoneal bypass and aponeurotomies however the patient's condition deteriorated, resulting in muscle compartment necrosis. On (b)(6) 2020, a surgical reintervention was performed, which included target limb amputation at or above the ankle. No procedural complications were reported, and the reintervention was considered successful. The adverse event was reported as resolved with sequelae.
Patient problems: Necrosis; Obstruction/Occlusion
MAUDE report 50519457 ↗MalfunctionMay 25, 2026Obstruction of Flow
AS PART OF POST-MARKET CLINICAL FOLLOW-UP (PMCF) REGISTRY FOR VXT AND FLIXENE GRAFTS THE FOLLOWING ADVERSE EVENT INFORMATION WAS PROVIDED REGARDING A VXT GRAFT. DURING CT SCAN THROMBOSIS OF THE LEFT-TO-RIGHT FEMOROFEMORAL BYPASS WAS IDENTIFIED. THE PATIENT IS ASYMPTOMATIC AND THE FOOT HAS NORMAL COLORATION WITH GOOD VENOUS FILLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25268179 ↗
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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