GORE-TEX Stretch Vascular Graft-Bifurcated SB2001DRecalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH BIFUR 20-10MM X 40CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132611867), received between Sep 14, 2022 and Sep 14, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anemia1
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2016, PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WHICH WAS TREATED WITH GORE-TEX® STRETCH VASCULAR GRAFT. REPORTEDLY, THE PATIENT HAD NOT COMPLICATIONS AND SURVIVED THE PROCEDURE, THE DEVICE WAS SUCCESSFULLY IMPLANTED AND RETAINED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. REPORTEDLY ON (B)(6) 2022, AN ADVERSE EVENT DESCRIBED AS POST-PROCEDURAL PERSISTENT BLEEDING SEEN AS ANEMIA WAS RECORDED WHICH NECESSITATED BLOOD TRANSFUSIONS (8 BAGS OF RED BLOOD CELLS FROM (B)(6) 2016). ACCORDING TO RECORDS THE ADVERSE EVENT RESOLVED ON (B)(6) 2022. REPORTEDLY ON (B)(6) 2016 A VOLUMINOUS RETROPERITONEAL HEMATOMA WAS DISCOVERED ON THE 8TH DAY OF REVISION AND A SURGICAL INTERVENTION WAS PERFORMED ON THE SAME DAY. HOWEVER, IT WAS RECORDED THAT THE GORE DEVICE DIDN'T CONTRIBUTE TO THE HEMATOMA. FURTHERMORE, THE PATIENT RECEIVED THE FOLLOWING ANTIPLATELET MEDICATIONS: ENOXAPARIN: FROM (B)(6) 2016, ASPIRIN: FROM (B)(6) 2016 TILL (B)(6) 2017. IT WAS REPORTED THAT THE ADVERSE EVENT WAS REGISTRY PROCEDURE RELATED AND THE PATIENT RECOVERED WITHOUT A SEQUELAE. ACCORDING TO THE PHYSICIAN, THE POSSIBLE CAUSE OF THE HEMATOMA MAY BE POOR STATE OF AORTA (VOLUMINOUS F
Patient problems: Anemia; Hematoma
MAUDE report 15417370 ↗
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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