FDA recall Z-1502-2022

Product

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Reason for recall

There is the potential that during implant deployment, the device may not properly deliver a implant.

Distribution

US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None

Key facts

Status

Ongoing

Initiation date

2022-06-24

Report date

2022-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pleasanton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2022