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…

Recall date

August 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3022-2018

FDA classification

Class II

Brand / firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Sold / distributed

Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.