Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL
Recalled Product
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Hazard / Issue
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.
Issued by
FDA
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