Gelweave™ 73301088/8Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881106359), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (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 16, 2026.
Most reported problems
Device problems
- Device Handling Problem1
- Use of Device Problem1
Patient problems
- Aneurysm1
- Aortic Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
PATIENT ADMITTED FOR ACUTE TYPE A DISSECTION DEBAKEY TYPE I BASED ON A PRE-EXISTING ASCENDING ANEURYSM, NO ANTICOAGULATION TREATMENT IN MEDICAL HISTORY, EMERGENT ARCH REPLACEMENT. PATIENT UNDERWENT AORTIC ARCH REPLACEMENT UNDER HYPOTHERMIC CIRCULATORY ARREST (25 °C) AND BILATERAL ANTEGRADE CEREBRAL PERFUSION. AFTER WEANING FROM CARDIOPULMONARY BYPASS AND ADEQUATE SUBSTITUTION OF PROTAMINE, PROGRESSIVE LEAKAGE OF PROSTHESIS IN THE AREA OF FIRST SIDE BRANCH OF PLEXUS PROSTHESIS AND ALONG BLACK SUTURE MARK OF MAIN BODY. CLINICAL RELEVANT BLOOD LOSS, DESPITE MASSIVE SUBSTITUTION OF FIBRINOGEN, THROMBOCYTES, PROTAMINE, DESMOPRESSIN AND FRESH FROZEN PLASMA NO IMPROVEMENT OF LEAKAGE OVER THREE HOURS. ADDITIONAL LOCAL FIBRIN GLUE AND OTHER HEMOSTYPTIC MATERIAL APPLIED ON TOP OF PROSTHETIC MATERIAL. AFTER WOUND CLOSURE NO RELEVANT BLEEDING, PATIENT IS EXTUBATED AND CLINICAL STABLE. PATIENT RECEIVED MASSIVE SUBSTITUTION OF BLOOD AND COAGULATION PRODUCTS BUT TOLERATED ALL VERY WELL. OPERATIVE TIME WAS PROLONGED BUT PATIENT RECOVERED UNEVENTFUL.
Patient problems: Aneurysm; Aortic Dissection
MAUDE report 10312145 ↗
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
- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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