ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
FDA Recall Z-3022-2018 · Posted None
Recalling FirmMicro Therapeutics Inc, Dba Ev3 Neurovascular
Recall StatusTerminated
Product CodeMCW
Date Initiated2018-08-10
Date Terminated2020-08-04
Product Quantity67 units
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.
Firm Action
Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
Root Cause
Process control
Distribution Pattern
Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.