FDA recall Z-1207-2018

Product

6F Taiga Guiding Catheter

Reason for recall

Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

Distribution

Japan

Key facts

Status

Terminated

Initiation date

2017-09-26

Report date

2018-04-04

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1207-2018