Class 2 Device Recall TurboHawk Peripheral Plaque Excision System

• Date Initiated by Firm: August 10, 2018
• Create Date: September 11, 2018
• Recall Status: Terminated on August 04, 2020
• Recall Number: Z-3022-2018
• Recall Event ID: 80831
• 510(K)Number: K111723
• Product Classification: Catheter, peripheral, atherectomy - Product Code MCW
• Product: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
• Code Information: Lot Number A495368
• Recalling Firm/ Manufacturer: Micro Therapeutics Inc, Dba Ev3 Neurovascular; 9775 Toledo Way; Irvine CA 92618-1811
• For Additional Information Contact: 949-837-3700
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
• Quantity in Commerce: 67 units
• Distribution: Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MCW and Original Applicant = EV3 INC