Gelsoft Plus™ 633014PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881115252), received between Apr 1, 2024 and Apr 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Hematemesis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
AS REPORTED PANTHER STUDY: EVENT REPORTED AS "POSSIBLY RELATED TO DEVICE" BUT NO DEVICE DEFICIENCY REPORTED, AORTA-DUODENAL FISTULA WITH HEMATEMESIS IN 2022. NOTE: SUBJECT HAD TELEPHONE FOLLOW UP FOR 5 YEAR FOLLOW UP VISIT - THIS IS WHEN THIS ADVERSE EVENT WAS DISCOVERED BY SITE. SUBJECT WAS TREATED AT DIFFERENT HOSPITALS FOR BOTH THE ENDOVASCULAR AND OPEN SURGICAL REPAIR AND THE STUDY SITE DO NOT HAVE FURTHER INFORMATION AT THIS TIME. SURGICAL INTERVENTION: ENDOVASCULAR REINTERVENTON BY STENT IN 2022, AND OPEN REPAIR AT A LATER DATE IN (B)(6) 2023 (TUBE PROSTHESIS -> BIFURCATED PROSTHESIS). TWO SEPARATE REINTERVENTIONS.
Patient problems: Hematemesis
MAUDE report 19010379 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.