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Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C f
Recalled September 19, 2018 · FDA recall Z-3022-2018 · Micro Therapeutics Inc,
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. · FDA Class II
Units
67 units
Sold at
Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Description
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.
Product
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Manufacturer(s)
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →