Medical DeviceView official recall notice →
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Brand / Firm
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Reason for recall
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Units affected
557 units
Description
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;