FDA recall Z-1564-2021

Product

VenaSeal Closure System

Reason for recall

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

Distribution

Distributed nationwide to MA, NY, VT, NH, ME

Key facts

Status

Ongoing

Initiation date

2021-03-23

Report date

2021-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

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