Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx10mm (UPN M00553550) due to risk of outer sheath tip detaching, potentially prolonging procedures. Affected units have specific lot numbers.
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific is recalling HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx10mm units with UPN M00553550. The outer sheath tip may detach during use, preventing proper stent expansion and requiring a procedure exchange, which can delay treatment.
The outer sheath's black tip can detach from the stent during use. If it remains around the stent saddle, the device won't expand properly, requiring the procedure to be exchanged for a new one. This can prolong the treatment time significantly.
Medical professionals using the HOT AXIOS Stent system for procedures are most at risk. Patients undergoing stent placement may experience longer treatment times if the device is affected.
Check for the UPN M00553550 on the device. Affected units have specific lot numbers listed in the recall notice, including 32868212 through 34512950.
Look for the UPN M00553550 on the device label to confirm if it's affected.
The outer sheath tip may detach during use, preventing proper stent expansion and requiring a procedure exchange, which can prolong treatment.
Check the device label for UPN M00553550. If affected, contact Boston Scientific for guidance on next steps.
Affected devices have specific lot numbers listed in the recall notice, including 32868212 through 34512950.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1035-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1035-2025 from Boston Scientific. 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.
