ADVANTA SLIDER GDS 22222Recalls & reported problems
Atrium Medical Corporation · 8MMX70CM, TW, H, ADVANTA VXT, GDS · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00650862222227), received between Jul 11, 2017 and Sep 18, 2026 — classified as 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (6 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. How this data works · Data updated Oct 13, 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-1988-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow6
- Device Operates Differently Than Expected1
- Patient-Device Incompatibility1
Patient problems
- Limb Pain4
- Obstruction/Occlusion4
- Ischemia2
- Thrombosis/Thrombus2
- Abscess1
- Hematoma1
- Implant Pain1
- Necrosis1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 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 developed acute lower extremity ischemia and presented with severe lower back pain radiating into both legs. On evaluation, the lower extremities were cold and tender, with absent palpable pulses and no sensory or motor deficits. CT angiography revealed a thrombus extending from the infrarenal aorta to the bilateral common iliac arteries.The patient underwent emergency surgical intervention, including a left axillo-femoral bypass and bilateral iliac, superficial femoral, deep femoral, and cross-bypass thrombectomies. A graft reintervention consisting of endovascular thrombectomy was successfully performed on (b)(6) 2022. Patency was restored, no amputation was required, and the adverse event subsequently resolved.
Patient problems: Ischemia; Limb Pain; Thromboembolism
MAUDE report 50816245 ↗InjurySep 12, 2026Obstruction of Flow
Patient problems: Limb Pain; Obstruction/Occlusion
MAUDE report 50745771 ↗InjurySep 12, 2026Obstruction of Flow
Patient problems: Limb Pain; Obstruction/Occlusion
MAUDE report 50745770 ↗InjurySep 11, 2026Obstruction of Flow
Patient problems: Implant Pain; Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 50740338 ↗InjurySep 11, 2026Obstruction of Flow
Patient problems: Ischemia; Limb Pain; Thrombosis/Thrombus
MAUDE report 50739454 ↗InjuryAug 31, 2026Obstruction of Flow
Patient problems: Obstruction/Occlusion; Stenosis
MAUDE report 50519242 ↗MalfunctionMay 3, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT ADVANTA VXT GRAFT WAS USED DURING THE PROCEDURE. THE PATIENT HAD SEVERAL ANASTOMOTIC PSEUDOANEURYSMS RESULTING FROM THE BYPASS SURGERY. THE REPORTED ISSUE WAS STATED TO BE RELATED TO THE PROCEDURE AND UNRELATED TO THE IMPLANTED GRAFT.
Patient problems: Abscess; Hematoma; Necrosis; Pain; Swelling/ Edema
MAUDE report 25062517 ↗MalfunctionJul 11, 2017Device Operates Differently Than Expected
REPORT RECEIVED STATED THAT DURING A FEMORAL-POPLITEAL (FEM-POP) BYPASS SURGERY THE SECOND LAYER OF THE GRAFT WAS LIFTING DURING THE REMOVAL OF THE HELIX..
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6703673 ↗
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
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
- ADVANTA SLIDER GDS 22187Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.