Boston Scientific Recalls AXIOS Stent and Delivery Systems Over Deployment Failures

What Happened

Boston Scientific Corporation has initiated a voluntary recall of specific units of the AXIOS Stent and Electrocautery-Enhanced Delivery System. The recall follows an increase in reports regarding stent deployment and expansion issues. If the stent fails to deploy or expand properly, it can lead to prolonged medical procedures or require additional endoscopic or surgical interventions to remove the device and close the puncture site.

Which Products Are Affected

The recall affects 59 units of the following product:

• Product Name: AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm
• Material Number (UPN): M00553690
• UDI-DI: 191506008093
• Recall Number: Z-1160-2026
• Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043.

The distribution of these units is worldwide, including the United States (nationwide and Puerto Rico) and over 50 other countries including Canada, Germany, Japan, and the United Kingdom.

What You Should Do

Healthcare facilities and providers should immediately check their inventory for the affected lot numbers listed above. If any of these units are found, they should be quarantined and not used. For further instructions on returning the products or obtaining replacements, contact Boston Scientific Corporation at 100 Boston Scientific Way, Marlborough, MA 01752.

Why This Matters

This is a Class I recall, the most serious classification, indicating that the device malfunction poses a significant risk to patient health. Failure of the stent to deploy correctly can necessitate invasive surgical or endoscopic procedures to correct complications and ensure patient safety.

Source

This recall information is provided by the FDA. Recall Number: Z-1160-2026.