Medtronic recalls sterile single-use blades for StraightShot M Series Handpiece and Fusion ENT systems due to increased tip breaks and wobble/vibration complaints. Affected product numbers and serials listed.
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 users reported more tip breaks and wobble/vibration. This could lead to unstable use during procedures.
The blades can break or vibrate during use, potentially causing instability in medical procedures. This could lead to unintended movement or injury to the patient or practitioner.
Healthcare professionals using Medtronic's StraightShot M Series Handpiece or Fusion ENT systems are most at risk. Patients undergoing procedures with these blades may also be affected.
Check for product numbers starting with REF 40A2500, 40R2000, 40R2500, 40S2000, 40S2500, 45A2000, 45A2500, 45R2000, 45R2500, or 45S2000. Look for specific lot/serial numbers listed in the recall notice.
Verify the product number and lot/serial number against the list provided in the recall notice to confirm if your blades are affected.
The recall states there have been increased complaints about tip breaks and wobble/vibration, so they are not recommended for use until confirmed safe.
Check the product numbers and lot/serial numbers against the list provided in the recall notice to determine if your blades are affected.
The recall notice does not specify a replacement process or remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0158-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0158-2022 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.
