Gelsoft Plus™ 631206PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE · Class 2 · Implant
Data updated Oct 13, 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 05037881115504), received between Jul 20, 2026 and Jul 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K162803, K955230); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2026Material Integrity Problem
Gelsoft Plus Bifurcate being implanted in a 44 year old male patient at (b)(6). A medial approach to the arm was made along the vascular pathway. Dissection was performed through layers until the brachial vein and superficial cutaneous brachial nerve were identified. Dissection of the deep layer was then performed, identifying the median nerve, brachial artery, and vein. The dissection extended into the axillary region, revealing no lesions at this level. Dissection continued distally, identifying the findings described 2 cm above the antecubital fossa. The proximal and distal edges of the brachial artery were reshaped. The brachial vein was ligated. A Fogarty suture No. 3-4-5 was passed proximally and distally, obtaining a single, fresh blood clot. The proximal and distal areas were irrigated with heparinized saline solution. A 6mm Dacron graft was placed with a proximal double-pillar anastomosis. Upon verifying the adequate seal of the anastomosis, it was confirmed that Hemorrhagic leakage was identified throughout the graft, so it was decided to remove it.No harm to the patient was noted , however it was considered a serious adverse event due to the increased surgery time.This r
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25869386 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162803, K955230. 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 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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