Micro Therapeutics Inc, Dba Ev3 Neurovascular: Medical Device Recall in 2018 - (Recall #: Z-3022-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 10, 2018

Date Posted: September 19, 2018

Recall Number: Z-3022-2018

Event ID: 80831

Reason for Recall:

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.

Status: Terminated

Product Quantity: 67 units

Code Information:

Lot Number A495368

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated