GORE-TEX Stretch Vascular Graft-Bifurcated SB2201DRecalls & reported problems
W. L. Gore & Associates, Inc. · STRETCH VASC GRAFT SW BIFUR 22-11mmX40cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132611881), received between Apr 26, 2022 and Jun 13, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Insufficient Device Problem Information1
Patient problems
- Aneurysm1
- Bacterial Infection1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Hypovolemic Shock1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR INFRARENAL FUSIFORM AORTIC ANEURYSM OF 54 MM CONFIRMED BY CTA WITH A GORE-TEX® VASCULAR GRAFT. DURING SURGERY, AN INTRAOPERATIVE HEMORRHAGIC SHOCK OCCURRED WITH BLOOD LOSS OF ABOUT 3.8 L, WHICH REQUIRED A BLOOD TRANSFUSION. BLEEDING PERSISTED SO THE DAY AFTER A REVISION SURGERY WAS PERFORMED ALLOWING EVACUATION OF A RETROPERITONEAL HEMATOMA. NO ACTIVE BLEEDING HAS BEEN FOUND. THE PATIENT WAS PUT IN THE ICU AND DECEASED 3 DAYS LATER FROM REFRACTORY MULTIPLE ORGAN FAILURE. THE PHYSICIAN STATED THAT THE OBSERVED COMPLICATIONS ARE NOT ATTRIBUTABLE TO OUR GORE DEVICE.
Patient problems: Aneurysm; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock
MAUDE report 14673424 ↗InjuryApr 26, 2022Contamination; Contamination
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR A SUBRENAL ABDOMINAL AORTIC ANEURYSM WITH A GORE-TEX® STRETCH VASCULAR GRAFT ¿ STANDARD-WALLED BIFURCATED. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED AS AN AORTO-BIILIAC BYPASS DURING A ROBOTIC-ASSISTED SURGERY ON (B)(6) 2020. IT WAS REPORTED THAT ON (B)(6) 2021, AFTER ABOUT 9 MONTHS, THE PROSTHESIS WAS EXPLANTED DUE TO AN INFECTION TO STREPTOCOCCUS ANGINOSUS.
Patient problems: Bacterial Infection
MAUDE report 14201314 ↗
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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