FDAAugust 10, 2018device
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
micro therapeutics inc dba ev3 neurovascularmicromicro therapeutics
Recall history
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