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.

Alligator Retrieval Device The device is intended for use in Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to Delamination and detachment of the PTFE (polytetrafluoroethylene) coating...

Date: October 5, 2016
Company: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Status: Terminated
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 Micro Therapeutics Inc, Dba Ev3 Neurovascular directly.

Affected Products

Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

Quantity: 3,337 units

Why Was This Recalled?

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Micro Therapeutics Inc, Dba Ev3 Neurovascular

Micro Therapeutics Inc, Dba Ev3 Neurovascular has 14 total recalls tracked by RecallDetector.

Related Recalls

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