Agent, Occluding, Vascular, Permanent
FDA adverse event reports and recall history for agent, occluding, vascular, permanent (product code PJQ), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 1,325
- Deaths
- 18
- Injuries
- 1,228
- Malfunctions
- 78
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2015-05-12TerminatedPackage design/selection
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
- Open, ClassifiedDevice Design
VenaSeal Closure System
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
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