Recall Z-3022-2018
Micro Therapeutics Inc, Dba Ev3 Neurovascular · initiated August 10, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Codes / lots: Lot Number A495368
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.
FDA-determined cause: Process control
Action taken
Medtronic began notifying the Consignees on 10-Aug-2018. Consignees were asked to quarantine and return affected product.
Details
- Recall number
- Z-3022-2018
- Initiated
- August 10, 2018
- Terminated
- August 4, 2020
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 67 units
- Distribution
- Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA