GORE-TEX Vascular Graft Pediatric Shunt VT35005LARecalls & reported problems
W. L. Gore & Associates, Inc. · VG T3.5MM X 5CM SILK · 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 00733132616053), received between Jun 16, 2021 and Jun 17, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow1
- Partial Blockage1
Patient problems
- Thrombosis/Thrombus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2021Partial Blockage; Partial Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT UNDERWENT A NORWOOD PROCEDURE UTILIZING A GORE-TEX® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT DEVICE. PHYSICIAN CONFIRMED ALL SHUNTS ARE ON PROPHYLACTIC HEPARIN UNTIL THEY¿RE ABLE TO TRANSITION TO ASPIRIN AND THAT ASPIRIN RESPONSIVENESS IS CHECKED IN EVERYONE PRIOR TO STOPPING HEPARIN. ON (B)(6) 2020, THE SHUNT IS FOUND TO BE PATENT BUT MILDLY NARROWED AT ITS PROXIMAL ANASTOMOSIS. A HEPARIN DRIP IS STARTED ON THE PATIENT. ON (B)(6) 2020 A CARDIAC CATHETER WITH A STENT IS PLACED IN THE GORE-TEX® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT. ON (B)(6) 2020 AN ECHO SHOWS THE PEDIATRIC SHUNT IS PATENT BUT THERE IS LESS FLOW THROUGH THE SHUNT WHEN COMPARED TO THE PREVIOUS ECHO WHICH COULD INDICATE PROXIMAL OR DISTAL NARROWING. ON (B)(6) 2020, SHUNT LIGATION AND TAKEDOWN IS PERFORMED AND A "YELLOWISH FLUID" IS FOUND AROUND THE SHUNT. SAMPLES FROM THE YELLOWISH FLUID PRODUCED NO GROWTH ON CULTURES.
Patient problems: Thrombosis/Thrombus
MAUDE report 12015843 ↗InjuryJun 16, 2021Obstruction of Flow; Obstruction of Flow
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2018, A PATIENT UNDERWENT A PATENT DUCTUS ARTERIOSUS LIGATION AS PART OF A BLALOCK-TAUSSIG SHUNT PROCEDURE UTILIZING A GORE-TEX® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT DEVICE. ON (B)(6), 2018 AT 0640, THERE WAS A PATIENT DECOMPENSATION EVENT WITH OXYGEN DESATURATION, BRADYCARDIA, HYPOTENSION AND CPR. A BEDSIDE ECHO DEMONSTRATED NARROWING AT THE PROXIMAL ANASTOMOSIS OF THE SHUNT DUE TO A POSSIBLE THROMBUS. THE PATIENT WAS TAKEN TO EMERGENT OR AND A SHUNT REVISION WAS PERFORMED. ON (B)(6), 2019 THE SHUNT WAS REMOVED WITH THE CREATION OF A BIDIRECTIONAL GLENN. PHYSICIAN CONFIRMED ALL SHUNTS ARE ON PROPHYLACTIC HEPARIN UNTIL THEY¿RE ABLE TO TRANSITION TO ASPIRIN AND THAT ASPIRIN RESPONSIVENESS IS CHECKED IN EVERYONE PRIOR TO STOPPING HEPARIN.
Patient problems: Thrombosis/Thrombus
MAUDE report 12011371 ↗
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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