FDA (Devices) recall action 98237
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.