Gelsoft Plus Vascular Prostheses 634006PERecalls & 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881166643), received between Jul 1, 2026 and Jul 1, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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
- Adverse Event Without Identified Device or Use Problem1
- Microbial Contamination of Device1
Patient problems
- Post Operative Wound Infection1
- Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem
EVENT REPORTED FROM PANTHER STUDY. PANTHER - (B)(6). SUBJECT (B)(6), A 66 YEAR-OLD, WHITE, MALE WITH OCCLUSIVE DISEASE, UNDERWENT OPEN SURGICAL REPAIR OF FEMOROPOPLITEAL ARTERY BYPASS WITH A GELSOFT PLUS STRAIGHT GRAFT ON (B)(6) 2026. THERE WERE NO REPORTED ISSUES WITH THE DEVICE FOLLOWING THE SURGERY, AND THE PATIENT WAS DISCHARGED BACK TO PRE-OP LIVING CONDITIONS ON POD(POST OPERATIVE DAY) 5. POST-OPERATIVELY (ON POD 28 - (B)(6) 2026), THE PATIENT PRESENTED WITH THE SERIOUS ADVERSE EVENT OF WOUND INFECTION. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT WITH HIGH FEVER AND PAIN IN THE LEFT GROIN. CLINICAL ASSESSMENT INDICATED A POSTOPERATIVE WOUND INFECTION FOLLOWING A FEMOROPOPLITEAL BYPASS, WITH SUSPECTED BYPASS GRAFT INFECTION (GELSOFT PLUS DEVICE). THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2026 WHERE INTRAVENOUS AMOXICILLIN/CLAVULANIC ACID THERAPY WAS INITIATED. THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL WOUND DEBRIDEMENT OF THE LEFT GROIN, DRAINAGE OF THE ABSCESS, AND PLACEMENT OF A VAC (VACUUM-ASSISTED CLOSURE) DEVICE. THE SITE REPORTED THIS EVENT ON (B)(6) 2026, AT WHICH TIME THE EVENT IS STILL ONGOING.)
Patient problems: Post Operative Wound Infection; Wound Infection
MAUDE report 25677486 ↗
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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