ADVANTA SLIDER GDS 22221Recalls & reported problems
Atrium Medical Corporation · 7MMX70CM, 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
- 5
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00650862222210), received between May 5, 2026 and Sep 29, 2026 — classified as 1 death, 4 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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-1987-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Obstruction of Flow3
- Patient-Device Incompatibility2
Patient problems
- Drug Resistant Bacterial Infection1
- Ischemia1
- Limb Pain1
- Obstruction/Occlusion1
- Purulent Discharge1
- Thrombosis/Thrombus1
- Wound Dehiscence1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 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.It was reported that following implantation of an Advanta VXT vascular graft, the patient developed pain in the left lower limb after gardening while crouching for an extended period. Doppler ultrasound confirmed thrombosis of the bypass graft. Clinical symptoms included a cyanotic, cold, and painful leg and foot.The patient underwent a successful percutaneous graft reintervention on (b)(6) 2020, including endovascular pharmacological thrombolysis. Graft patency was restored, no amputation was required. The adverse event subsequently resolved.
Patient problems: Limb Pain; Thrombosis/Thrombus
MAUDE report 50930507 ↗InjurySep 18, 2026Patient-Device Incompatibility
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 an infection of the left anterior femorotibial prosthesis, requiring graft removal and revascularization. On (b)(6) 2019, swelling was noted at the Scarpa approach, with a large inflammatory mass and underlying hematoma. Clinical findings included fever (38.2°C) and elevated inflammatory markers (CRP 150 mg/L). Bacteriological analysis confirmed penicillin-resistant Staphylococcus aureus infection. An infectious disease consultation on (b)(6) 2019 confirmed infection of the left anterior femorotibial prosthesis.A surgical reintervention was successfully performed on (b)(6) 2019 and included graft explantation and revascularization using a vein graft. No amputation was required. Following the procedure, patency was restored, and the adverse event resolved.
Patient problems: Drug Resistant Bacterial Infection
MAUDE report 50820383 ↗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 Duplex ultrasound, which confirmed occlusion of the femoropopliteal bypass graft. Based on the findings, surgical intervention was planned. A successful percutaneous procedure was performed on (b)(6) 2026 to treat the occlusion. Following the procedure, the adverse event resolved without further reported complications.
Patient problems: Obstruction/Occlusion
MAUDE report 50519560 ↗InjuryAug 31, 2026Patient-Device Incompatibility
Patient problems: Purulent Discharge; Wound Dehiscence
MAUDE report 50518994 ↗DeathMay 5, 2026Obstruction of Flow
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.