Medtronic recalls its TurboHawk Plus 6F directional atherectomy system for small vessel use due to tip detachment risk. Affected units have catalog number THP-S and GTIN 007630:00402419.
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.
Medtronic is recalling its TurboHawk Plus Directional Atherectomy System 6F for small vessels because it has design similarities to a device that caused tip detachment and embolization. This could lead to serious complications if the device malfunctions during use.
The device shares design features with a previously recalled model that caused tips to detach during use, potentially leading to embolization (blockage of blood vessels). This risk occurs during the procedure when the device is deployed in small blood vessels.
Patients undergoing peripheral vascular procedures with the affected device are most at risk. The recall applies to specific units sold with catalog number THP-S.
Check for the catalog number THP-S on the device packaging or label. The product was sold with GTIN 00763000402419 for peripheral vascular procedures.
Look for the catalog number THP-S on the device packaging or label to confirm if it is affected.
The device has design similarities to a previously recalled model that caused tip detachment and embolization, which could lead to serious complications during use.
The affected device has catalog number THP-S.
Check for the catalog number THP-S on the device packaging or label. The product was sold with GTIN 00763000402419 for peripheral vascular procedures.
We’ve drafted a message you can send ev3 to request your refund or repair — edit it as you like.
Subject: Recall Z-0695-2022 — ev3 ev3 Hello, I own a ev3 that is covered by recall Z-0695-2022 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.
