Gelsoft Plus™ 631508PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT · Class 2 · Implant
All models of Gelsoft Plus (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 05037881115337), received between Dec 15, 2021 and Dec 15, 2021 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Local Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SERIOUS ADVERSE EVENTS WERE REPORTED RELATED TO GELSOFT PLUS PROSTHESES. IN (B)(6) 2021, (B)(4) DIFFERENT PATIENTS WERE IMPLANTED WITH GLESOFT PLUS STRAIGHT PROSTHESES. ALL (B)(4) PATIENTS EXPERIENCED SYSTEMIC SEPTIC SYMPTOMS WITH FEVER, HIGH INFLAMMATORY LOCAL RESPONSE WITHIN THE FIRST 24 HOURS POSTOPERATIVELY. IN ALL (B)(4) CASES BACTERIA/INFECTION WAS NOT DETECTED IN WOUND SWABS NOR IN BLOOD CULTURES. IN ONE CASE, THE PROSTHESIS HAD TO BE EXPLANTED, LEADING TO LIFE-THREATENING COMPLICATIONS AND TO IRREVERSIBLE CONSEQUENTIAL DAMAGE WITH PRESUMABLY LIFELONG CARE.
Patient problems: Local Reaction
MAUDE report 13007988 ↗
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 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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