Medtronic recalls HawkOne Directional Atherectomy System (H1-M and H1-M-INT) due to tip damage causing detachment and embolization. Affected units sold in specific regions with catalog numbers.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Medtronic is recalling its HawkOne Directional Atherectomy System (catalog numbers H1-M and H1-M-INT) because reports show tip damage during use can lead to detachment and embolization. This poses a risk of blockages in blood vessels, which could cause serious complications for patients undergoing vascular procedures.
The system's tip can become damaged during use, causing it to detach from the catheter. When this happens, debris can travel through the bloodstream and block blood vessels, potentially leading to serious complications.
Patients undergoing vascular procedures with the HawkOne system are most at risk. The recall affects specific models sold in the U.S. and Europe with catalog numbers H1-M and H1-M-INT.
Check for catalog numbers H1-M or H1-M-INT on the device packaging. The system is sold in the U.S. and Europe with specific GTINs listed in the recall notice.
Look for catalog numbers H1-M or H1-M-INT on the device packaging or documentation.
Reports have been received of tip damage during use which can cause the tip to detach and embolize, potentially blocking blood vessels.
Check for catalog numbers H1-M or H1-M-INT on the device packaging or documentation. The system is sold in the U.S. and Europe with specific GTINs listed in the recall notice.
The recall does not require immediate discontinuation; however, users should check the device packaging for catalog numbers to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0450-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0450-2022 from Medtronic. 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.
