ADVANTA SLIDER GDS 22114Recalls & reported problems
Atrium Medical Corporation · 4-6MMX45CM, SW, SH, 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
- 11
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00650862221145), received between Dec 3, 2018 and Dec 27, 2024 — classified as 4 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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-1993-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Material Separation3
- Contamination /Decontamination Problem1
- Leak/Splash1
- Material Frayed1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Inflammation1
- Insufficient Information1
- No Information1
- No Known Impact Or Consequence To Patient1
- Rupture1
- Tissue Damage1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2024Material Twisted/Bent; Material Twisted/Bent
DURING THE AVG PROCEDURE, WHILE CONNECTING THE GRAFT GDS TO THE TUNNELER FOR THE GRAFT DEPLOYMENT PROCESS, SEVERE TWISTING OF THE GRAFT BODY OCCURRED. THE GRAFT WAS REMOVED, AND THE SURGERY WAS COMPLETED USING A CONSIGNED PRODUCT OF THE SAME MODEL (SN (B)(6)). IT APPEARS THAT DURING THE PROCESS OF CONNECTING THE GDS TO THE TUNNELER, NOT ONLY THE GDS BUT ALSO THE GRAFT ROTATED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21024205 ↗MalfunctionJan 19, 2024Material Separation; Material Separation
InjuryJan 18, 2024Material Separation; Material Separation
DURING AN AVG SURGERY THE VXT GRAFT (22114) TUNNELING PROCESS, A LOT OF GDS CAME OUT AND TISSUE WAS BURIED, SO THE GRAFT WAS REMOVED AND THE SURGERY WAS COMPLETED WITH A NEW VXT GRAFT (22114). HOWEVER, EVEN WITH THE NEW GRAFT, A LOT OF THE GDS TIP CAME OUT. THE PATIENT WHO UNDERWENT SURGERY WITH THE NEW GRAFT IS CURRENTLY DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18539770 ↗InjuryJan 8, 2024Material Separation; Material Separation
DURING AVG SURGERY TUNNELING PROCESS, A LOT OF GDS CAME OUT (MORE TISSUE ACCUMULATES BETWEEN GRAFT AND GDS WHEN THE TUNNELER AND GDS ARE CONNECTED), THE GDS TIP CAME OUT. AND TISSUE WAS BURIED, SO THE GRAFT WAS REMOVED AND THE SURGERY WAS COMPLETED WITH A NEW PRODUCT. THERE WAS A 40 MINS. DELAY IN SURGERY HOWEVER, PATIENT WHO UNDERWENT SURGERY WITH THE NEW PRODUCT ARE CURRENTLY DOING WELL, NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18467550 ↗MalfunctionJan 8, 2024Leak/Splash; Leak/Splash
MalfunctionFeb 22, 2022Material Frayed; Material Frayed
REPORT RECEIVED STATED THAT DURING THE ARTERIOVENOUS GRAFT (AVG) OPERATION, EPTFE STANDS ADHERED TO THE HELIX UPON REMOVAL. THE OPERATION WAS PERFORMED WITH THE SAME MODEL GRAFT AND THERE WAS NO PROBLEM OR DELAY IN THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13581735 ↗InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem
MalfunctionFeb 11, 2020Material Split, Cut or Torn
DURING ARTERIOVENOUS GRAFT SURGERY, GRAFT WAS TORN.
Patient problems: Tissue Damage
MAUDE report 9697040 ↗MalfunctionSep 16, 2019Adverse Event Without Identified Device or Use Problem
InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem
AFTER GRAFT TRANSPLANTATION, THERE WAS INFLAMMATION. THE USER ASSUMED THAT THE PROBLEM OCCURRED ELSEWHERE RATHER THAN THE GRAFT PROBLEM.
Patient problems: Inflammation
MAUDE report 8910258 ↗MalfunctionDec 3, 2018Contamination /Decontamination Problem
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
- 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
- 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.