Device product
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Z-3022-2018
Product summary
- Event
- Event 80831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 units
- Official record key
device-enforcement:Z-3022-2018
Official wording
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.
Code information: Lot Number A495368
Distribution pattern: Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
Derived failure modes
-
Unknown
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.