Medtronic recalls HawkOne Directional Atherectomy System (H1-S, H1-S-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 (H1-S and H1-S-INT models) because reports show tip damage during use can lead to detachment and embolization. This poses a risk of blockages in blood vessels if the tip breaks off during procedures.
The tip of the device can become damaged during use, causing it to detach from the catheter. If the detached tip moves into blood vessels, it can block flow or cause embolism, potentially leading to serious complications.
Healthcare professionals using the HawkOne system for peripheral vascular procedures are most at risk. Patients undergoing treatments with this device may be affected if the tip detaches.
Check for catalog numbers H1-S or H1-S-INT on the device packaging. The system is intended for peripheral vasculature procedures and sold in specific regions with listed GTINs.
Look for catalog numbers H1-S or H1-S-INT on the device packaging to confirm if it is affected.
The device is not safe for use as reported tip damage can cause detachment and embolization. Users should check if their device is recalled.
Check the device packaging for catalog numbers H1-S or H1-S-INT. If affected, contact Medtronic for guidance.
No, the device is not intended for use in coronary, carotid, iliac, or renal vasculature.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0451-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0451-2022 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.
