VECTRA®, VASCULAR ACCESS GRAFT 10002-5020-003Recalls & reported problems
Thoratec Corporation · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024011316), received between Sep 3, 2021 and Jun 1, 2023 — classified as 2 injuries, 1 malfunction.
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
- Crack1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2023Infusion or Flow Problem; Infusion or Flow Problem
THE PATIENT WAS IMPLANTED WITH 5MM 20CM DENSE REINFORCEMENT TYPE AND POLYTETRAFLUOROETHYLENE (PTFE) COMPOSITE ON (B)(6) 2020. AN OBSTRUCTION WAS CONFIRMED ON (B)(6) 2023 BY ECHOCARDIOGRAPHY AND WAS REMOVED BECAUSE A LAYER DEVIATION WAS FOUND. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2023 AND THE VECTRA GRAFT WAS REPLACED WITH A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 17039595 ↗MalfunctionFeb 1, 2022Crack; Mechanical Problem; Crack; Mechanical Problem
IT WAS REPORTED THAT AFTER THE TUNNELER WAS REMOVED, THE GRAFT WAS CRACKED DURING THE PULLING TO ADJUST THE POSITION IN THE BLOOD VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13418269 ↗InjurySep 3, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT ON (B)(6) 2021 DURING DIALYSIS, VENOUS PRESSURE INCREASED AND WHEN CONTRAST IMAGING WAS PERFORMED THE AREA FROM THE LOOP BECAME INVISIBLE. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED THE NEXT DAY. THE GRAFT WAS OCCLUDED AGAIN A WEEK LATER, AND THE OCCLUDED AREA WAS TO BE REPLACED. HOWEVER, WHEN THE VEIN WAS INCISED AND THE GRAFT WAS EXCISED, THE OUTER AND INNER LAYERS WERE SEPARATED. THE ENTIRE GRAFT WAS THEREFORE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12426006 ↗
Other Prosthesis, Vascular Graft, Of Less Then 6mm Diameter devices
- ADVANTA SLIDER GDS 22115Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22116Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall1 report
- ADVANTA SLIDER GDS 22267Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- 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 22058Atrium 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
- IMPRA® ePTFE Vascular Grafts F8006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER7 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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