Recall Z-3022-2018— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Name: FDA recall Z-3022-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-10

Class II · Terminated

Class II FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2018-08-10, terminated 2020-08-04. It names one FDA 510(k) clearance: K111723. 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: 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..

Recalling firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2018-08-10
Terminated: 2020-08-04
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.·cleared 2011-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.