Gelweave™ 731508Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05037881105079), received between Jun 26, 2017 and Mar 27, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem5
- Leak/Splash4
- Use of Device Problem2
- Device Handling Problem1
- Insufficient Device Problem Information1
Patient problems
- No Known Impact Or Consequence To Patient3
- Blood Loss1
- Insufficient Information1
- No Code Available1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PHYSICIAN USED A 8MM GELWEAVE GRAFT ON HIS BENTALL CASE TODAY. THE GRAFT OOZED ALL OVER IT'S ENTIRE SURFACE AREA, FOR THE ENTIRE CASE.
Patient problems: Insufficient Information
MAUDE report 18985073 ↗MalfunctionOct 18, 2018Leak/Splash; Leak/Splash
THE REPORTED EVENT WAS REPORTED AS FOLLOWS: BLOOD BLED THROUGH DURING IMPLANT. HOSPITAL DOES NOT PRE-SOAK GRAFTS.
Patient problems: Blood Loss
MAUDE report 7976917 ↗MalfunctionOct 5, 2017Leak/Splash; Use of Device Problem; Material Integrity Problem; Leak/Splash; Use of Device Problem; Material Integrity Problem
INITIAL INFORMATION ON EVENT RECEIVED AT VASCUTEK ON 07-SEP-17 SIMPLY STATED: LEAK FROM FABRIC. FURTHER INFORMATION WAS RECEIVED ON 13-SEP-17 STATING BLOOD LEAKAGE FROM THE BODY OF THE GRAFT, THE GELWEAVE GRAFT WAS USED FOR BLOOD TRANSMISSION. AFTER GRAFTS WERE ANASTOMOSED END-TO-END, WHEN BLOOD FLOW WAS PASSED THROUGH, UNUSUAL LARGE AMOUNTS OF BLOOD LEAKAGE WAS IDENTIFIED FROM THE GRAFT BODY AND THE BLOOD ACCUMULATED IN THE OPERATIVE FIELD. ALTHOUGH THE LEAKING DID NOT STOP, THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED, AFTER THE GRAFT WAS TAKEN OUT AND THE VESSEL WAS LIGATED. NO SERIOUS INJURY TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6916593 ↗MalfunctionSep 11, 2017Leak/Splash; Use of Device Problem; Material Integrity Problem; Device Handling Problem; Leak/Splash; Use of Device Problem; Material Integrity Problem; Device Handling Problem
THE EVENT WAS REPORTED TO VASCUTEK ON 14TH AUGUST AS FOLLOWS; AFTER A STRAIGHT CONNECTOR FOR ARTIFICIAL CARDIO PULMONARY BYPASS WAS INSERTED INTO THE GRAFT FOR BLOOD TRANSMISSION DURING ASCENDING AORTA REPLACEMENT SURGERY AND BLOOD FLOW WAS COMMENCED, LEAKAGE WAS IDENTIFIED IN PART OF THE GRAFT BODY. ADDITIONAL INFORMATION RECEIVED ON 16TH AUGUST; VASCUTEK WAS INFORMED THAT INTERVENTION BY USE OF HAEMOSTATIC AGENT (HYDROFIT) WAS REQUIRED TO STOP LEAKAGE AND THAT THE GRAFT HAD NOT BEEN PRE-SOAKED IN SALINE PRIOR TO USE AS RECOMMENDED IN IFU.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6854445 ↗MalfunctionAug 29, 2017Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem
WHEN BLOOD TRANSMISSION STARTED, OOZING WAS NOT OBSERVED, BUT AFTER A WHILE BLOOD SIGNIFICANTLY OOZED FROM THE ENTIRE SURFACE OF THE GRAFT. AMOUNT OF BLOOD LOSS IS UNKNOWN. THE GRAFT WAS NOT EXPLANTED. IT IS UNKNOWN HOW THE LEAKAGE WAS STOPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6826639 ↗MalfunctionJul 13, 2017Material Integrity Problem; Material Integrity Problem
UPDATED INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT: THE GELWEAVE GRAFT WAS NOT IMPLANTED BY THE USER, BUT WAS USED FOR AXILLARY CANNULATION.
Patient problems: No Information
MAUDE report 6709814 ↗MalfunctionJun 26, 2017Material Integrity Problem; Material Integrity Problem
CLINICIAN HAD AN ISSUE WITH AN 8MM GELWEAVE GRAFT ON (B)(6) 2017 THAT WAS BEING USED AS PART OF AN ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CASE. IT WAS REPORTED TO BE LEAKING THROUGHOUT BEING DESCRIBED AS A "SOAKER HOSE". THE REPORT ALSO ADVISED THAT THE GRAFT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6666148 ↗
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.