Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to The Distal Flush Tool (DFT) accessories that were...

Date: August 10, 2018
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

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

Quantity: 67 units

Why Was This Recalled?

The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

Where Was This Sold?

This product was distributed to 10 states: AZ, CA, FL, GA, KS, KY, LA, MI, NE, TX

Affected (10 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