Recall Z-1824-2024— LeMaitre Vascular, Inc.

Name: FDA recall Z-1824-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-17

Class II · Ongoing

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2024-04-17. It names one FDA 510(k) clearance: K910372. Product: Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.. Reason: The guide tip can become damaged and result in the tip detaching..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-17
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K910372 — INTIMAX THROMBECTOMY CATHETERApplied Vascular Devices, Inc.·cleared 1991-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.