Gelweave™ 734028/10ADPRecalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA ANTE-FLO · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881121031), received between Jul 13, 2017 and Oct 30, 2019 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K090987); 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.
Most reported problems
Device problems
- Device Operates Differently Than Expected3
- Material Integrity Problem1
- Material Puncture/Hole1
Patient problems
- Fever3
- Seroma3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2019Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem
THE EVENT WAS REPORTED AS FOLLOWS: WHEN THE PHYSICIAN WAS ANASTOMOSING THE DISTAL END OF THE GRAFT, THE PHYSICIAN OBSERVED THAT THE GRAFT HAD A HOLE WHICH WAS MUCH BIGGER THAN A PIN HOLE. THE PHYSICIAN SUTURED THE HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9254300 ↗InjuryJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
VASCUTEK HAVE RECEIVED NOTIFICATION OF THE EVENT THAT WAS DESCRIBED AS 39-DEGREE FEVER ONE WEEK AFTER THE IMPLANT DAY. A SEROMA AROUND THE IMPLANTED GRAFT WAS OBSERVED AS WELL. INITIALLY PROCEDURE WAS COMPLETE AS USUAL. THE PATIENT IS IN CLINICAL FOLLOW-UP STAGE AND IS ON THE WAY TO RECOVERY.
Patient problems: Fever; Seroma
MAUDE report 6710368 ↗InjuryJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
VASCUTEK HAVE RECEIVED NOTIFICATION OF THE EVENT THAT WAS DESCRIBED AS 39-DEGREE FEVER AFTER SEVERAL DAYS FROM THE IMPLANT DAY. A SEROMA AROUND THE IMPLANTED GRAFT WAS OBSERVED AS WELL. INITIALLY PROCEDURE WAS COMPLETE AS USUAL. PATIENT WAS GIVEN ANTIPYRETIC TO REDUCE THE FEVER AND IS IN THE RECOVERY.
Patient problems: Fever; Seroma
MAUDE report 6710366 ↗InjuryJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
VASCUTEK HAVE RECEIVED NOTIFICATION OF THE EVENT THAT WAS DESCRIBED AS 39-DEGREE FEVER AFTER SEVERAL DAYS FROM THE IMPLANT DAY. A SEROMA AROUND THE IMPLANTED GRAFT WAS OBSERVED AS WELL. INITIALLY PROCEDURE WAS COMPLETE AS USUAL. PATIENT WAS GIVEN ANTIPYRETIC TO REDUCE THE FEVER AND IS IN THE RECOVERY.
Patient problems: Fever; Seroma
MAUDE report 6710362 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090987. 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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