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VenaSeal™
MEDTRONIC, INC. · Model VS-404 · UDI-DI 00763000240776
PJQ
Prescription
0
510(k) clearances
1,325
Adverse events (18 deaths)
2
Recalls
5
Facilities
Description
CLOSURE SYSTEM VS-404 VENASEAL US EA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-23 | Medtronic Inc. | Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter. |
| 2015-04-28 | Covidien LLC | Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.