Gelsoft Plus™ 633006PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis STRAIGHT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881115207), received between Oct 21, 2016 and Aug 31, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- No Information1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2021Material Integrity Problem; Material Integrity Problem
GELSOFT PLUS STRAIGHT (CAT 633006P-G, LOT 17877209, S/N (B)(6)) GRAFT LEAKAGE WAS REPORTED DURING USE. THE CLINICIAN COMPRESSED THE GRAFT (AT THE LEAK SITE) TO ARREST THE LEAK. THIS RESULTED IN THE GRAFT OCCLUDING AND THE SUBSEQUENT EXPLANTATION OF THE GRAFT. THE GELSOFT BRANDED DEVICE WAS REPLACED WITH A GORE MANUFACTURED PTFE GRAFT.
Patient problems: Obstruction/Occlusion
MAUDE report 12390666 ↗MalfunctionOct 21, 2016Leak/Splash; Leak/Splash
REPORTED TO VASCUTEK AS: WHILE SUTURING GRAFT AT IMPLANT, DR. FOUND BLOOD LEAKAGE FROM A HOLE IN GRAFT. HOLE WAS REPAIRED WITH SUTURE HOWEVER DR. THEN DECIDED TO EXPLANT GRAFT AND REPLACE WITH NEW ONE. NO CLAMPS WERE USED DURING PROCEDURE AND GRAFT PRE-SOAKED AS PER IFU INDICATIONS. BLOOD LOSS REPORTED AS MINIMAL AT LESS THAN 2CC. EXPLANTED GRAFT TO BE RETURNED FOR INVESTIGATION.
Patient problems: No Information
MAUDE report 6046495 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page