Recall Z-3022-2018 ยท MCW Catheter, Peripheral, Atherectomy
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
| Date | Aug 10, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product. |
| Quantity | 67 units |
| Distribution | Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111723 | TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc., Oct 27, 2011 |