VECTRA®, VASCULAR ACCESS GRAFT 10002-6050-001Recalls & reported problems
Thoratec Corporation · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813024011453), received between Apr 15, 2021 and Jan 30, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).
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.
Most reported problems
Device problems
- Infusion or Flow Problem2
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Thrombosis/Thrombus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) REVEALED A REINFORCEMENT THREAD HAD POPPED OUT OF THE VECTRA GRAFT. BIOPSY FORCEPS WERE USED TO REMOVE THE THREAD, AS SHUNT BLOOD FLOW WAS LOW AND A THROMBUS HAD ADHERED TO THE THREAD. THIS EVENT WAS LIKELY DUE TO FREQUENT PUNCTURES TO THE SAME POINT ON THE SIDE OF THE ARTERY NEAR THE FIRST AND SECOND POINTS.
Patient problems: Thrombosis/Thrombus
MAUDE report 16268103 ↗MalfunctionDec 23, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE ECHOCARDIOGRAM CONFIRMED LINEAR MATERIAL IN THE GRAFT LUMEN WHICH WAS REMOVED WITH BIOPSY FORCEPS. THE REINFORCING THREAD WAS SEVERED BY A PUNCTURE OPERATION AT THE DIALYSIS FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16043322 ↗MalfunctionOct 29, 2022Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AN ECHOCARDIOGRAPHY REVEALED AN OBSTRUCTION IN THE LUMEN OF THE ARTIFICIAL VESSEL. THE OBSTRUCTION WAS REMOVED WITH BIOPSY FORCEPS DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND WAS REVEALED TO BE A REINFORCING THREAD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695566 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE BROKE WHEN PULLED TO ADJUST THE POSITION AFTER BEING PLACED UNDER THE SKIN. THE OUTER LAYER WAS PEELING AND TORN. THE PATIENT WAS NOT INJURED. THE ACCOUNT REQUESTED THE MANUFACTURING HISTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11673505 ↗
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
- 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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