PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: April 17, 2024 #Z-1824-2024

Product Description

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.

Details

Recalling Firm
LeMaitre Vascular, Inc.
Units Affected
5,604 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
Location
Burlington, MA

Frequently Asked Questions

What product was recalled?
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.. Recalled by LeMaitre Vascular, Inc.. Units affected: 5,604 units.
Why was this product recalled?
The guide tip can become damaged and result in the tip detaching.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1824-2024.