VECTRA®, VASCULAR ACCESS GRAFT 10002-5040-001Recalls & 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 00813024011323), received between Mar 2, 2022 and Oct 4, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A VECTRA VASCULAR ACCESS GRAFT IMPLANTED ON (B)(6) 2022. INITIAL PUNCTURE AND DIALYSIS WAS PERFORMED ON (B)(6) 2022. AFTER DIALYSIS, THE NEED WAS REMOVED, WITHOUT RESISTANCE, AND GAUZE WAS APPLIED TO STOP THE BLEEDING. WHEN THE GAUZE WAS REMOVED, A THREAD-LIKE SUBSTANCE CAME OUT OF THE PUNCTURE WOUND. THE SUBSTANCE WAS CUT AND THE ARTIFICIAL BLOOD VESSEL WAS STILL IN USE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 15538806 ↗InjuryAug 30, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A THROMBUS ATTACHED TO A FREQUENT PUNCTURE SITE. ECHOCARDIOGRAPHY SHOWED LINEAR MATERIAL IN THE LUMEN OF THE GRAFT. THE THROMBUS WAS REMOVED WITH BIOPSY FORCEPS AND A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED.
Patient problems: Thrombosis/Thrombus
MAUDE report 15321554 ↗MalfunctionMar 2, 2022Mechanical Problem; Mechanical Problem
WHEN THE VECTRA GRAFT WAS IMPLANTED UNDER THE SKIN AND PULLED NEAR THE TOP OF THE LOOP, A CRACK APPEARED IN THE OUTER LAYER, SO IT WAS DISCONTINUED AND REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13652392 ↗
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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