Recall of specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System due to detachment of outer sheath distal black tip

A Dear Healthcare Professional Letter has been issued by Boston Scientific to inform healthcare professionals about the recall of specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System due to reports of the outer sheath distal black tip detaching from the device. In cases where the stent was deployed, it was observed that the separated black sheath tip can remain around the stent saddle, preventing proper expansion and leading to delivery catheter breakage. Additional interventions may be required to remove the stent, retrieve any fragments, and close the puncture site, with risk of infection or peritonitis from content leakage. Healthcare professionals are advised to identify, quarantine and return all affected products. Further distribution or use of any remaining affected products should cease immediately. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.