Gelweave™ 731608Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis BIFURCATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881105819), received between Oct 8, 2020 and May 26, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Most reported problems
Device problems
- Material Integrity Problem1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Renal Failure1
- Ruptured Aneurysm1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2021 A GELWEAVE BIFURCATE GRAFT APPEARED TO LEAK DURING A LEAK TEST (COMPLETED ON SITE AT THE HOSPITAL) ALLEGEDLY AFTER BEING IMPLANTED AND THEN EXTRACTED FROM THE BODY. THE EVENT WAS REPORTED AS DEVICE RELATED. DEVICE IS NOT AVAILABLE AS IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11884304 ↗InjuryOct 8, 2020Obstruction of Flow; Obstruction of Flow
PATIENT WAS IMPLANTED WITH A GELWEAVE BIFURCATE DEVICE ON (B)(6) 2020. THE FOLLOWING DAY, THE CLINICIAN CONFIRMED THROMBOSIS POST-OP. THE PATIENT SHOWED LOW LEVELS OF BLOOD PRESSURE. PATIENT SUFFERED HYPOVOLEMIC SHOCK DUE TO AAA RUPTURE AND ACUTE RENAL FAILURE WHICH RESULTED IN PATIENT DEATH. CLINICIAN CONFIRMED THAT THE EVENT IS NOT RELATED TO A DEVICE FAILURE AND THAT IT WAS RELATED TO A PATIENT PRE-EXISTING CONDITION.
Patient problems: Renal Failure; Ruptured Aneurysm; Thrombosis/Thrombus
MAUDE report 10648081 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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