Gelweave™ 731608XL55Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis EXTRA LONG BIFURCATE · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 16, 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 05037881107639), received between Apr 22, 2020 and Mar 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow2
- Defective Device1
- Material Frayed1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Material Frayed; Defective Device; Material Frayed; Defective Device
EVENT WAS REPORTED AS; THE SURGEON HAD TO SUTURE THE GRAFT ON THE FRAYING AREA. THERE WAS NO INJURY TO THE PATIENT. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00027 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0181.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21685808 ↗InjuryJun 29, 2023Obstruction of Flow; Obstruction of Flow
HIS EVENT WAS REPORTED TO VASCUTEK LTD VIA THE PANTHER STUDY PROGRAMME AS FOLLOWS: ON (B)(6) 2021 A GELWEAVE BIFURCATE GRAFT WAS IMPLANTED TO TREAT AORTO-FEMORAL ANEURYSM. SHORTLY AFTER PROCEDURE POST-OPERATIVE ACUTE ISCHEMIA DUE TO EARLY OCCLUSION OF GELWEAVE DEVICE IDENTIFIED. TO RESOLVE THE EVENT MEDICATION (UNKNOWN TYPE) WAS GIVEN TO THE PATIENT. THROMBUS WAS REMOVED FROM THE DEVICE. 12X38MM BENTLEY STENT WAS IMPLANTED IN ADRENAL AORTA ABOVE GELWEAVE GRAFT TO AVOID STENOSIS OF ANASTOMOTIC SITE. PATIENT RECOVERED WITHOUT SEQUELAE. THE SITE HAS INDICATED THAT THIS EVENT IS POSSIBLY RELATED TO THE PROCEDURE, DEVICE AND PATIENT PRE-EXISTING CONDITIONS.
Patient problems: Insufficient Information
MAUDE report 17223645 ↗InjuryApr 22, 2020Obstruction of Flow; Obstruction of Flow
ORIGINAL INFORMATION RECEIVED: ON THE 26-MAR-20 VASCUTEK LTD. RECEIVED THE FOLLOWING INFORMATION FROM OUR DISTRIBUTOR (TERUMO FRANCE): THE EVENT WAS REPORTED AS FOLLOWS: A PATIENT UNDERWENT AN AORTO BI-FEMORAL BYPASS PROCEDURE AND A GELWEAVE EXTRA LONG BIFURCATE DEVICE WAS USED. THE PATIENT SUFFERED IMMEDIATE THROMBOSIS. INTERVENTION WAS PERFORMED (UNKNOWN TYPE). THE PATIENT WAS LATER TRANSFERRED TO INTENSIVE CARE. ADDITIONAL INFORMATION RECEIVED: FOLLOWING THE PROCEDURE, AND DURING THE NIGHT THE PATIENT PRESENTED WITH AN INCOMPLETE ACUTE ISCHEMIA OF THE RIGHT LOWER LIMB. DOPPLER IMAGING CONFIRMED AN OCCLUSION IN THE RIGHT LEG. INTERVENTION PERFORMED. SURGICAL APPROACH MADE AT THE LEVEL OF THE RIGHT SCARPA. THE FOGARTY BRINGS BACK A SIGNIFICANT QUANTITY OF FRESH THROMBUS. ARTERIOGRAPHY SHOWS THROMBUS WITHIN THE BODY OF THE PROSTHESIS AND IN THE LEFT LEG. THE LAPAROTOMY IS REDONE AS WELL AS THE LEFT SCARPA. AORTIC CLAMPING, UPON OPENING OF THE AORTIC ANASTOMOSIS; THE BODY OF THE PROSTHESIS IS THE SEAT OF AN ADHERENT THROMBUS WHICH IS REMOVED WITH FORCEPS. FOGARTY COMPLEMENTARY IN THE 2 LEGS AND THE DEEP FEMORALS. CLOSURE OF THE SURGICAL ACCESS WAS COMPLETED. FAVORABLE EVOLUTION THEN
Patient problems: Thrombosis
MAUDE report 9985167 ↗
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page