| Class 2 Device Recall TurboHawk Peripheral Plaque Excision System | |
Date Initiated by Firm | August 10, 2018 |
Create Date | September 11, 2018 |
Recall Status1 |
Terminated 3 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
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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
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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 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = MCW
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