FDA recall Z-1644-2022

Medtronic Inc. · Class II · device

Product

EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Reason for recall

Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.

Distribution

worldwide

Key facts

Status: Ongoing
Initiation date: 2022-07-14
Report date: 2022-09-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1644-2022