FDA recall Z-1467-2022

Covidien Llc · Class II · device

Product

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

Reason for recall

Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

Distribution

AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain

Key facts

Status: Ongoing
Initiation date: 2022-06-07
Report date: 2022-08-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2022