FDA (Devices) recall action 96049
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
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.
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 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.