Medtronic recalls sterile single-use blades for StraightShot M Series Handpiece and Fusion ENT systems due to increased tip breaks and wobble/vibration. Affected products include specific blade models and serial numbers.
There was an increase in complaints related to tip breaks and wobble/vibration.
Medtronic is recalling sterile single-use blades used in their StraightShot M Series Handpiece and Fusion ENT systems because customers reported more tip breaks and wobble/vibration. This could lead to improper use during medical procedures.
The blades have been reported to break or vibrate during use, which could cause improper cutting or injury during medical procedures. This is a mechanical issue with the blade design.
Medical professionals using these blades in ENT (ear, nose, throat) procedures are most at risk. Patients receiving care with these blades may also be affected.
Check for the product numbers listed in the recall notice, including specific blade types like Sinus Blades, Tonsillectomy Blades, and Tracheal Blades. Look for the serial numbers provided for each product.
Review the product numbers and serial numbers listed in the recall notice to confirm if your blades are affected.
Medtronic has received complaints about increased tip breaks and wobble/vibration in these blades.
No, but you should check if your blades are affected and consider using a different blade if you are at risk.
Check the product numbers and serial numbers listed in the recall notice for your specific blade type.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0156-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0156-2022 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.
