Ev3 Turbohawk Perpheral Plaque Excision System for recall
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Why was Ev3 Turbohawk Perpheral Plaque Excision System for 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number A495368
- Product
- ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Quantity
- 67 units
- Distribution
- Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China
- Recall date
- September 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)