ADVANTA SLIDER GDS 22075Recalls & reported problems
Atrium Medical Corporation · 6MMX80CM, SW, H, ADVANTA VXT, GDS · Class 2 · Implant
All models of ADVANTA SLIDER GDS (51)
Data updated Oct 18, 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 00650862220759), received between Jul 27, 2016 and Jun 27, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Recalls naming this device
- May 3, 2024Class IIOpen, 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-1971-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Integrity Problem1
- Migration1
Patient problems
- Death1
- Device Embedded In Tissue or Plaque1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Material Integrity Problem; Migration; Material Integrity Problem; Migration
REPORT RECEIVED STATED THAT ON (B)(6) 2025 A VXT GRAFT WAS INSERTED PRODUCT CODE 22075 6X80CM SERIAL NUMBER (B)(6). PATIENT PRESENTED AGAIN ON (B)(6) 2025 WHERE IT WAS DISCOVERED PATIENT HAD HEMATOMA AT THE RIGHT INFRACLAVICULAR INCISION. DURING THE EXPLORATION OF INCISION SITE, THE SURGEON NOTED "THERE WERE PROLENE SUTURES IN THE AXILLARY ARTERY AND THE AXILLARY LIMB OF THE AXILLARY BIFEMORAL BYPASS WAS COMPLETELY AVULSED AND RETRACTED INTO THE SUBCUTANEOUS TISSUE OF THE RIGHT CHEST WALL." A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. GETINGE REF. (B)(4).
Patient problems: Device Embedded In Tissue or Plaque; Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 22344898 ↗MalfunctionJul 27, 2016Insufficient Device Problem Information
THE PHYSICIAN REPORTED HE WAS PERFORMING A FEMORAL-POPLITEAL BYPASS ON A PATIENT THAT RESULTED IN THE PATIENT HAVING EXCESSIVE BLEEDING FROM THE POPLITEAL VEIN. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HE EXPIRED ON (B)(6) 2016 OF MULTI-ORGAN FAILURE.
Patient problems: Death
MAUDE report 5825295 ↗
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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 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
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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