Gelweave™ 732211XL55Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis EXTRA LONG BIFURCATE · 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881107660), received between Apr 23, 2020 and Dec 18, 2023 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. 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
- Defective Device1
- Infusion or Flow Problem1
Patient problems
- Death1
- Hematoma1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Ischemia1
- Respiratory Distress1
- Thrombosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2023Defective Device; Defective Device
DEVICE FAILURE/ DEFICIENCY WAS DUE TO LOOSE KNIT AT THE GRAFT BIFURCATION. BLOOD LEAKAGE AT THE BIFURCATION LEVEL. PATIENT OUTCOME: NEED TO SEW THE GRAFT HOLE WITH A 5.0 THREAD TO GET HEMOSTASIS OF THE GRAFT. THIS REPORT IS BEING SUBMITTED AS A INITIAL / FINAL FOR MFG. REPORT TO PROVIDE EVENT CLOSURE INFORMATION FOR COMP (B)(4).
Patient problems: Insufficient Information
MAUDE report 18343321 ↗DeathApr 23, 2020Infusion or Flow Problem; Infusion or Flow Problem
ON THE 26-MAR-20 VASCUTEK LTD. RECEIVED THE FOLLOWING INFORMATION FROM OUR DISTRIBUTOR (TERUMO (B)(4)): PATIENT UNDERWENT PROCEDURE FOR OPEN ABDOMINAL AORTIC ANEURYSM AND AORTO-BI-ILIAC BYPASS AND REIMPLANTATION BILATERAL RENAL ARTERIES (EXACT DATE UNKNOWN AT THIS TIME) THE ADDITIONAL NARRATIVE ON THE EVENT IS AS FOLLOWS: "THE PATIENT DIED ON (B)(6) 2020: HIS CONDITION WAS COMPLICATED DURING THE NIGHT OF (B)(6) 2020 WITH ISCHEMIA OF THE RIGHT LOWER LIMB AND THROMBOSIS OF THE RIGHT RENAL ARTERY WHICH JUSTIFIES A FIRST SURGICAL REINTERVENTION ON (B)(6) 2020 FOR THROMBECTOMY RIGHT RENAL AND BILATERAL EXTERNAL ILIAC, RIGHT RENAL BYPASS WITH PROSTHESIS, BILATERAL ILIOFEMORAL BYPASSES WITH PROSTHESIS, ANGIOPLASTY STENTING OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AND PLACEMENT OF JJ PROBE IN THE LEFT URETER . DURING THE NIGHT OF (B)(6) 2020, THE PATIENT PRESENTED A HEMORRHAGIC SHOCK RELATED TO A HEMATOMA OF THE RIGHT PSOAS. IT THEN PROGRESSES TO MESENTERIC ISCHEMIA AND ARDS. DEATH ON (B)(6) 2020."
Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Respiratory Distress; Thrombosis
MAUDE report 9989505 ↗
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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