Gelweave™ 732410108/8S4Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis COSELLI THORACOABDOMINAL GRAFT · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881107233), received between Sep 25, 2018 and Dec 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
1 other recall cover devices cleared under the same FDA submission (K090987, K162794); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Leak/Splash; Leak/Splash
(OPERATION TYPE: THORACOABDOMINAL AORTIC REPLACEMENT EVENT) EVENT REPORTED AS PARTIAL OOZING FROM THE MAIN BODY AND BRANCHES OF THE GRAFT AND POSTOPERATIVE INFECTION: WHEN THE CHEST WAS REOPENED AND THORACOABDOMINAL AORTIC REPLACEMENT WAS PERFORMED USING THE GELWEAVE COSELLI GRAFT, PARTIAL OOZING WAS NOTED FROM THE SURFACE OF THE MAIN BODY AND BRANCHES OF THE GRAFT. AS THE OOZING WAS FROM SOME SPOTS RATHER THAN THE ENTIRE GRAFT, THE SURGEON INDICATED THAT THE GELATINE MAY BE UNEVEN. HYDROFIT WAS THEN USED TO STOP OOZING. AFTER THE SURGERY, THE PATIENT BECAME INFECTED AND IS STILL HOSPITALIZED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT: 9612515-2024-00082 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0105.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20877455 ↗MalfunctionSep 25, 2018Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2018, THE PATIENT UNDERWENT A PROCEDURE TO HAVE A GELWEAVE COSELLI THORACOABDOMINAL GRAFT IMPLANTED. DURING THE PROCEDURE, THE CLINICIAN REPORTED THAT THE RIGHT RENAL BRANCH ROOT WAS LEAKING. PROTAMINE WAS APPLIED TO ARREST THE LEAK, WHICH WAS UNSUCCESSFUL. THE CLINICIAN THEN APPLIED A SUTURE TO THE AFFECTED AREA AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7905082 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090987, K162794. One submission often covers many models, so check the product and lot details in each record.
- Z-2542-2021 · Jul 8, 2021 · TerminatedThe Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Val
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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