Gelweave™ 734026CX4RMSRecalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis LUPIAE BRANCHED GRAFT · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881006598), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (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 16, 2026.
Most reported problems
Device problems
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2020Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation
EVENT WAS REPORTED TO VASCUTEK LTD. AS FOLLOWS: BLOOD LEAKAGE: ON (B)(6) 2020, THE GELWEAVE LUPIAE DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN, AND FOUND TO BE DEVELOPED CARDIAC TAMPONADE UPON EXAMINATION. THE PATIENT HAD RIGHT SMALL THORACOTOMY AND RECOVERED FROM CARDIAC TAMPONADE. THE PHYSICIAN SUSPECTED TYPE-1 END LEAK FROM THE PERIPHERAL PART OF THE OPEN STENT GRAFT AND PLACED THE STENT GRAFT. DURING ANGIOGRAPHY AFTER THE PLACEMENT OF THE STENT GRAFT, A LEAKAGE OF THE CONTRAST AGENT FROM THE DEVICE WAS OBSERVED. THE PHYSICIAN ATTEMPTED THORACOTOMY ON THE PATIENT AND THE BLOOD LEAKAGE WAS IDENTIFIED FROM A PART NEAR THE RADIOPAQUE MARKER ON THE OPPOSITE SIDE OF THE TRI-BRANCH OF THE DEVICE. THE PHYSICIAN SUTURED THE LEAK SITE WITH A STITCH TO ACHIEVE HEMOSTASIS. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ABNORMALITIES HAD BEEN OBSERVED WHEN THE DEVICE HAD IMPLANTED. THEREFORE, IT IS UNKNOWN WHEN THE BLOOD LEAKAGE WAS OCCURRED. THE PHYSICIAN SUSPECTS THE RADIOPAQUE MARKER ATTACHMENT ON THE DEVICE MIGHT BE A CAUSE OF THE BLOOD LEAKAGE AS THE LEAK SITE WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10604774 ↗
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