FDA recall Z-1824-2024

LeMaitre Vascular, Inc. · Class II · device

Product

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

Reason for recall

The guide tip can become damaged and result in the tip detaching.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.

Key facts

Status
Ongoing
Initiation date
2024-04-17
Report date
2024-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2024