Medtronic recalls its TurboHawk Plus Directional Atherectomy System 6F for potential tip detachment causing embolization during peripheral vascular procedures.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Medtr: ev3 recalls its TurboHawk Plus Directional Atherectomy System 6F for potential tip detachment that could cause embolization. This risk affects doctors performing peripheral vascular procedures with the specific model.
The device's design resembles another product that had tip detachment issues leading to embolization. This could cause blockages in blood vessels during procedures.
Healthcare professionals using the specific model for peripheral vascular procedures are most at risk. Patients undergoing these procedures with the recalled device may be affected.
Check for the catalog number THP-M on the device. The product was sold for peripheral vascular procedures.
Look for the catalog number THP-M on the device label.
The recall indicates potential tip detachment that could cause embolization, but the device is not inherently dangerous without specific use conditions.
Check for the catalog number THP-M on the device label. The product was sold for peripheral vascular procedures.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send ev3 to request your refund or repair — edit it as you like.
Subject: Recall Z-0694-2022 — ev3 ev3 Hello, I own a ev3 that is covered by recall Z-0694-2022 from ev3. 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.
