FDA-Device2021-05-19Class III

VenaSeal Closure System

Medtronic Inc.
Hazard

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

Sold states
Distributed nationwide to MA, NY, VT, NH, ME
Affected count
154,152 units
Manufactured in
4600 Nathan Ln N, Plymouth, MN, United States
Products
VenaSeal Closure System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2021

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