Gelsoft Plus™ 633010PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT · Class 2 · Implant
- 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 05037881115238), received between May 29, 2024 and Nov 11, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Misconnection” (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
- Misconnection1
- Off-Label Use1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Off-Label Use; Off-Label Use
EVENT DATE: ON 16 OCT 2024. IMPLANT DATE: ON (B)(6) 2024. EVENT WAS REPORTED AS WEAVING DEFECTS. THE SURGICAL GRAFT WAS USED AS A CIRCULATION LINE FOR AORTIC REPLACEMENT PROCEDURE, AND AFTER CLAMP RELEASED, SURGEON FOUND BLOOD EJECT FROM THE SURFACE OF SURGICAL GRAFT (NOT THE ANASTOMOSIS SITE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20650845 ↗DeathMay 29, 2024Misconnection; Misconnection
EVENT REPORTED BY EMAIL FROM CARDIOTHORACIC BUSINESS MANAGER ON 02 MAY 24 GELSOFT PLUS STRAIGHT GRAFT IMPLANTED IN (B)(6) HOSPITAL WAS LEAKING THROUGH THE GRAFT , NOT AT THE ENDS. GRAFT WAS SUCCESSFULLY IMPLANTED. EVENT INTAKE FORM WAS RECEIVED ON 08 MAY 24 10MM GRAFT WAS BEING USED FOR CANNULATION AND WAS NOT IMPLANTED HOWEVER IT HAS BEEN DISGARDED AND IS NO LONGER AVAILABE TO BE RETURNED. PATIENT PRE-CONDITION WAS ENTERED AS POSTOP VSD - VENTRICULAR SEPTAL DEFECT. POOR LEFT VENTRICULAR AND RIGHT VENTRICULAR FAILURE PREPARATION FOR ECMO ,THE PATIENT HAS SINCE PASSED AWAY, CLINICIAN STATED " THE CONDUIT ISSUE IS NOT A CAUSE OF DEATH". AS PER EVENT INTAKE FORM THIS WAS NOT RELATED TO A DEVICE FAILURE/ DEFICIENCY. THIS REPORT IS BEING SUBMITTED TO PROVIDE INITIAL - FINAL EVENT INFORMATION FOR MANUFACTURING REPORT #0612515-2024-00032 COMPLAINT (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19414780 ↗
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.