Boston Scientific Recalls HOT AXIOS Stent Systems Due to Deployment and Expansion Issues

What Happened

Boston Scientific Corporation has issued a voluntary recall for its HOT AXIOS Stent and Electrocautery-Enhanced Delivery System. The recall was initiated following increased reports of issues regarding the deployment and expansion of the stent. According to the FDA, the most common outcome of these difficulties is the prolongation of the procedure to exchange the device. However, the most serious foreseeable outcome involves a cascade of events requiring additional endoscopic or surgical intervention to remove the stent and close the puncture site if the first flange fails to deploy or expand.

Which Products Are Affected

The recall specifically affects the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (8mm x 8mm).

• Material Number (UPN): M00553530
• UDI-DI: 8714729904557
• Quantity: 150 units
• Recall Number: Z-1162-2026
• Affected Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423, 36190575, 36191222, 36194448, 36218745, 36227778, 36227779, 36241500, 36271259, 36280398, 36293880, 36300839, 36301620, 36343103, 36343104, 36364646, 36425887, 36469811, 36471228, 36491879, 36492660, 36506029, 36510220, 36510221, 36513401, 36513402, 36513403, 36517139, 36517220, 36525208, 36525209, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792, 36853596, 36865505, 36873631, 36873632, 36873906, 36874863, 36904228, 36904229, 36904230, 36907002, 36907003, 36907004, 36907028, 37102533, 37102534, 37102535, 37102536, 37102537, 37459567, 37459568, 37459569, 37459570, 37463133, 37470670, 37498192, 37511243, 37519095, 37519096, 37844029, 37519097, 37520927, 37530320, 37530321, 37530333, 37533308, 37541933, 37571927, 37571928, 37579364, 37579366, 37579367, 37580630, 37585525, 37585526, 37589261, 37589262, 37594668, 37649481, 37649482, 37649483, 37650631, 37694052, 37699011, 37699012, 37708202, 37779125, 37779126, 37780822, 37780823, 37780824, 37823589, 37823590, 37827568, 37827569, 37833165, 37833176, 37834499.

What You Should Do

Healthcare facilities and distributors should immediately identify and quarantine any remaining inventory of the affected lot numbers. Boston Scientific Corporation, located at 100 Boston Scientific Way, Marlborough, MA 01752, has initiated this recall voluntarily. Providers should follow the firm’s specific instructions for the return or exchange of these devices to prevent use in clinical settings.

Why This Matters

This has been classified as a Class I recall, the most serious level of recall, indicating that the device defect could lead to significant medical complications or the need for invasive surgical intervention to correct deployment failures.

Source

Information provided by the FDA.