ADVANTA SLIDER GDS 22115Recalls & reported problems
Atrium Medical Corporation · 4-7MMX45CM, SW, SH, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00650862221152), received between Mar 19, 2017 and Nov 5, 2024 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (5 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-1994-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Deformation5
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Integrity Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Fluid Discharge1
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
AFTER AN ARTERIOVENOUS GRAFT (AVG) SURGERY OF THE LEFT ARM, ABNORMAL BLOOD FLOW LEVELS WERE OBSERVED. UPON CUTTING IT OPEN, IT WAS DISCOVERED THAT THE MIDDLE PART OF THE GRAFT WAS TORN. BY VISUAL INSPECTION OF THE GRAFT, BOTH OF THE INNER AND OUTER SURFACE SEEMS TO BE TORN. TO VERIFY THE GRAFT, THE END OF VXT 22115, WHICH HAD BEEN REMOVED, WAS REPLACED WITH VXT 22012, AND THE GRAFT WAS RECONNECTED. THE SURGERY WAS DELAYED BY 30 MINUTES TO 1 HOUR WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20615495 ↗MalfunctionMar 7, 2024Break; Break
MalfunctionMay 1, 2023Material Deformation; Material Deformation
MalfunctionApr 30, 2023Material Deformation; Material Deformation
MalfunctionApr 3, 2023Material Deformation; Material Deformation
AFTER OPENING, THE THICKNESS OF THE GRAFT WAS NOT CONSISTENT, WE REQUESTED A RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16667702 ↗MalfunctionApr 3, 2023Material Deformation; Material Deformation
AFTER OPENING, THE THICKNESS OF THE GRAFT WAS NOT CONSISTENT, WE REQUESTED A RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16667696 ↗MalfunctionFeb 21, 2023Material Deformation; Material Deformation
THE HOSPITAL CONSISTENTLY USES THE SAME MODEL GRAFT, AND UNLIKE USUAL USE, IT IS SAID THAT THE UPPER PART WAS THIN AND THE LOWER PART WAS THICK BASED ON THE BLUE LINE OF THE GRAFT. HE WANTS TO ASK THE MANUFACTURER IF THERE IS ANY PROBLEM WITH USING THE NEEDLE WHEN THE THIN PART IS DIALYSIS. THERE WAS NO PROBLEM WITH THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16410291 ↗MalfunctionApr 19, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING RINSING BEFORE AVF SURGERY, AND AS A RESULT OF PRELIMINARY EXPERIMENTS THROUGH BLOOD VESSELS BY EXTRACTING THE PATIENT'S BLOOD BEFORE SURGERY AT THAT TIME, STENOSIS OCCURRED DUE TO THE REMARKABLY THIN BLOOD VESSEL THICKNESS ON ONE SIDE. ONE SIDE OF THE THIN SIDE IS NOT MAINTAINED IN THE FORM OF A TUBE, AND THE OTHER SIDE IS SHRUNK. PROCEDURE COMPLETED WITH ANOTHER DEVICE SAME MODEL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14140816 ↗InjuryMar 19, 2017Adverse Event Without Identified Device or Use Problem
GRAFT WAS WEEPING CLEAR FLUID NOT BLOOD AFTER IMPLANTATION. THE CLEAR SERUM FLUID WAS SWEATING THROUGH THE GRAFT CONTINUALLY. THE GRAFT HAD TO BE EXPLANTED AND NEW GRAFT WAS USED.
Patient problems: Fluid Discharge
MAUDE report 6416357 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER devices
- ADVANTA SLIDER GDS 22116Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall1 report
- ADVANTA SLIDER GDS 22011Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22061Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22016Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22267Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- IMPRA® ePTFE Vascular Grafts F8006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER7 reports
- IMPRA® ePTFE Vascular Grafts F7006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER6 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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