Gelsoft Plus Vascular ProsthesesRecalls & reported problems across all models
Vascutek Ltd · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Gelsoft Plus Vascular Prostheses model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 49 models of Gelsoft Plus Vascular Prostheses by Vascutek Ltd in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2025 and Jul 1, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Gelsoft Plus Vascular Prostheses recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 18, 2025Open, 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 · names 49 of these models · Recall details · FDA record ↗
Most reported Gelsoft Plus Vascular Prostheses problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
- Wound Infection1
Gelsoft Plus Vascular Prostheses models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gelsoft Plus Vascular Prostheses 634006PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall1 report
- Gelsoft Plus Vascular Prostheses 631508PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall1 report
- Gelsoft Plus Vascular Prostheses 636006PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636007PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636008PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636010PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636012PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636014PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636016PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635018PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635020PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635022PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635024PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 634007PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 634008PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633006PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633007PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633008PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633010PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633012PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633014PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633016PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632518PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632520PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632522PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632524PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631506PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631507PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631510PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631512PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631514PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631516PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631218PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631220PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631222PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631224PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631206PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631407PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631608PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631809PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632010PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632211PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632412PEPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631407P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631608P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631809P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632010P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632211P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632412P50EPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
Recent Gelsoft Plus Vascular Prostheses adverse event reports
The 2 most recent reports across all models, 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 ↗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 Vascutek Ltd products
All Vascutek Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page