Gelsoft Plus Vascular Prostheses 631508PERecalls & reported problems
Vascutek Ltd · Gelsoft Plus Straight · Class 2 · Implant
All models of Gelsoft Plus Vascular Prostheses (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881166827), received between Oct 27, 2025 and Oct 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Dec 18, 2025Class IIOpen, Classified
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Z-1492-2026 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
EVENT OF GRAFT LEAKAGE REPORTED FORM (B)(6). A 69-YEAR-OLD PATIENT WITH AORTIC VALVE INSUFFICIENCY WAS IMPLANTED WITH A 631508PE GELSOFT PLUS GRAFT ON (B)(6)2025, LEAKAGE WAS NOTED NEXT TO THE MARKING STRIP ON THE GRAFT AFTER IMPLANT. THE PATIENT WAS NOT INJURED THE DEFECT WAS DETECTED BEFORE CLOSURE AND THE DEVICE EXPLANTED AND A SIMILAR PRODUCT WAS IMPLANTED IN ITS PLACE. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00087 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388711 ↗
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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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