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U.S. Department of Health and Human Services

Class 2 Device Recall TurboHawk Peripheral Plaque Excision System

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 Class 2 Device Recall TurboHawk Peripheral Plaque Excision Systemsee related information
Date Initiated by FirmAugust 10, 2018
Create DateSeptember 11, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-3022-2018
Recall Event ID 80831
510(K)NumberK111723 
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
Productev3 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
FEI Number 3004904811
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 2		Process control
ActionMedtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
Quantity in Commerce67 units
DistributionDistribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MCW
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