Z-3022-2018 Class II Terminated
FDA device recall Z-3022-2018 was initiated by Micro Therapeutics Inc, Dba Ev3 Neurovascular on August 10, 2018 and is designated Class II. 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 … The recall status is terminated (terminated August 4, 2020). Affected quantity: 67 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2018
- Initiation Date
- August 10, 2018
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67 units
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.
Distribution Pattern
Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Code Information
Lot Number A495368