FDA recall Z-3022-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-08-10

Report date

2018-09-19

Termination date

2020-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3022-2018