Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

LeMaitre 5F Plus Over the Wire Embolectomy Catheter Recalled by LeMaitre Vascular, Inc. Due to There has been an increased trend in reports...

Date: March 23, 2020
Company: LeMaitre Vascular, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LeMaitre Vascular, Inc. directly.

Affected Products

LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Quantity: 43315

Why Was This Recalled?

There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LeMaitre Vascular, Inc.

LeMaitre Vascular, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report