Gelsoft Plus™ 636006PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT · Class 2 · Implant
- 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 05037881115023), received between May 18, 2018 and Aug 13, 2019 — classified as 1 injury, 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 (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.
Most reported problems
Device problems
- Device Handling Problem1
- Device Operates Differently Than Expected1
- Material Deformation1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2019Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
THE EVENT WAS REPORTED AS FOLLOWS: AFTER SUTURING OF THE GRAFT AND GRAFT SUPPLY RESTORING, THERE WAS LEAKAGE THROUGH THE GRAFT NOTICED. DOCTOR WAITED FOR 15 MINUTES BUT THE OOZING DID NOT STOP. THE GLUE WAS APPLIED TO STOP LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8886818 ↗InjuryMay 18, 2018Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation
VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6) IN (B)(6) 2017, THE EVENT WAS DESCRIBED AS FOLLOWS: GELSOFT PLUSTM STRAIGHT GRAFT WAS USED FOR CAROTID BYPASS. IMPLANT OCCURRED IN (B)(6) 2016. THE GRAFT BECAME ELONGATED OVER TIME (1-YEAR PERIOD) TO THE POINT IT WAS BEGINNING TO ERODE THROUGH THE SKIN. AS A RESULT, THE GRAFT WAS REPLACED ((B)(6) 2018).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7525090 ↗
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.