Ev3 recalls TurboHawk peripheral plaque excision system model THS-LX-C due to incompatible Distal Flush Tool accessories causing inability to remove excised material during surgery.
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.
Ev3 is recalling its TurboHawk peripheral plaque excision system with large vessel extended tip for calcium (model THS-LX-C) because the included Distal Flush Tool accessories may not work properly with the catheter. This could prevent surgeons from removing excised material during procedures, potentially affecting surgical outcomes.
The Distal Flush Tool accessories in this lot number are not compatible with the TurboHawk LX-C catheter. This incompatibility may cause the system to be unable to remove excised material from the catheter tip during surgery, which could impact the procedure's effectiveness.
Surgeons using the TurboHawk peripheral plaque excision system model THS-LX-C for vascular procedures are affected. Those performing surgeries with this specific model are most at risk.
Check for the model THS-LX-C on the product packaging. The affected lot number is A495368. This recall applies to the TurboHawk peripheral plaque excision system for surgical use.
Look for the model THS-LX-C and lot number A495368 on the product packaging.
The Distal Flush Tool accessories in this lot number are not compatible with the TurboHawk LX-C catheter, which may cause the system to be unable to remove excised material during surgery.
The recall record does not specify any remedy steps for affected products.
The recall describes a potential inability to remove excised material during surgery, but does not mention risks of injury to users.
We’ve drafted a message you can send Ev3 Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-3022-2018 — Ev3 Neurovascular Ev3 Neurovascular Hello, I own a Ev3 Neurovascular that is covered by recall Z-3022-2018 from Ev3 Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
