ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Reported: September 19, 2018 Initiated: August 10, 2018 #Z-3022-2018
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.
Details
- Recalling Firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Units Affected
- 67 units
- Distribution
- Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular. Units affected: 67 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2018. Severity: Moderate. Recall number: Z-3022-2018.
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