Gelsoft Plus™ 632010PRecalls & reported problems
Vascutek Ltd · Gelsoft Plus Gelatin Impregnated Knitted Vascular Prosthesis BIFURCATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881115542), received between Jan 31, 2019 and Jan 21, 2025 — classified as 1 death, 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
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
- Material Integrity Problem2
- Appropriate Device Problem Term/Code Not Available1
- Improper or Incorrect Procedure or Method1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Death1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
EVENT DATE: (B)(6) 2024. IMPLANT DATE: (B)(6) 2024. THE PATIENT UNDERWENT VASCULAR GRAFT REPLACEMENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER ANASTOMOSIS OF THE PROXIMAL PORTION, BLOOD LEAKAGE OCCURRED FROM THE Y-GRAFT BIFURCATION. THE DAMAGED SITE WAS THEN REPAIRED ON SITE, AND THE SURGERY WAS CONTINUED. SUBSEQUENTLY, THE SURGERY WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: VASCULAR GRAFT REPLACEMENT FOR ABDOMINAL AORTIC ANEURYSM BLOOD LOSS: UNKNOWN THIS REPORT IS BEING SUBMITTED AS AN INITIAL- FINAL TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0075.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21197631 ↗MalfunctionMar 16, 2021Material Integrity Problem; Material Integrity Problem
TC (B)(4) REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A GELSOFT PLUS BIFURCATE LEAKED FROM THE BIFURCATION (APPROX. 5ML OF BLOOD LEAKED). THE LEAK SITE WAS SUTURED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY FURTHER INCIDENT. THE PATIENT DID NOT SUFFER ANY HARM OR INJURY. ALSO THE SITE REPORTED THAT NO FORCEPS/CLAMPS WERE USED ON THE LEAK SITE; BUT ADVISED THAT THE BIFURCATION AREA MAY HAVE BEEN "PULLED", THOUGH THIS IS UNCONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11493580 ↗MalfunctionJan 20, 2021Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem
EVENT WAS REPORTED TO VASCUTEK LTD AS FOLLOWS: BLOOD LEAKAGE: BLOOD LEAKAGE WAS IDENTIFIED FROM BRANCH ROOT PART OF THE GELSOFT PLUS BIFURCATE WHEN THE DEVICE WAS IMPLANTED. THE PHYSICIAN SUTURED THE LEAK PART, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11200098 ↗DeathJan 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # 9612515-2019-00001 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.
Patient problems: Death
MAUDE report 8293095 ↗
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.
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