Gelweave™ 736012Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
- 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 05037881105345), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Off-Label Use1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use
A 7-YEAR-OLD CHILD WAS TREATED FOR IMPLANTATION OF A BERLIN HEART DUE TO RHYTHMIC DILATED HEART DISEASE ON THE (B)(6) 2025. IMPLANTATION OF THE DEVICE TOOK PLACE WITH THE NEED TO INSTALL A 12 MM DIAMETER DACRON (GELWEAVE STRAIGHT DEVICE) PROSTHESIS. A HEMOSTATIC RECOVERY WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ABNORMAL BLOOD OOZING WAS OBSERVED FROM THE PROSTHESIS TISSUE. THE SURGEON REINFORCED THIS TISSUE BY APPLYING A SPRAY OF "COSEAL" BIOLOGICAL GLUE TO ENSURE THE WATERTIGHTNESS OF THE SYSTEM. THE OOZING OBSERVED WAS GENERALIZED OVER THE ENTIRE PROSTHESIS AND WAS NOT LIMITED TO THE SUTURE AREAS. SURGICAL REVISION/ INTERVENTION WAS REQUIRED. THE HEART TRANSPLANT WAS CARRIED OUT LATER. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00032 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21686515 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.