FDA-Device2018-09-19Class II
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Hazard
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.
Sold states
Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Affected count
67 units
Manufactured in
9775 Toledo Way, N/A, Irvine, CA, United States
Products
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3022-2018Don't want to check this manually?
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