Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: N/A
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The AXIOS Stent and Electrocautery-Enhanced Delivery System is used in various medical procedures to assist with stent placement. Patients may rely on this device for effective treatment of certain medical conditions.
The stent may fail to deploy or expand as intended, leading to complications during medical procedures. This increases the time needed for the procedure and may require additional medical interventions.
This recall is not part of a broader industry pattern.
Patients using the AXIOS Stent may face delays in treatment and potential additional procedures, increasing healthcare costs and risks.
The material number and lot numbers can usually be found on the product packaging or accompanying documentation.
Refund or replacement processing may take 4-6 weeks after submission.
Keep all purchase receipts and any communications with the manufacturer for your records.
The recalled product is the AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm, Material Number (UPN): M00553660. It was distributed worldwide, including the US and Puerto Rico, and had multiple lot numbers.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Boston Scientific is recalling 806 EndoVive Safety PEG Kits sold nationwide. The recall concerns BD ChloraPrep Triple Swabsticks with open or compromised seals that could compromise sterility or dry the antiseptic solution. Hospitals and patients should stop using the kits immediately and follow the manufacturer's recall instructions.
Boston Scientific recalled 266 units of the HOT AXIOS Stent on December 19, 2025. Reports indicated deployment and expansion problems, posing risks of prolonged procedures and additional surgical interventions. Consumers must stop using the device immediately and follow the manufacturer's instructions.
Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.
Boston Scientific recalled 150 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows increased reports of stent deployment and expansion issues, which could lead to serious medical interventions. Healthcare providers and patients must stop using the device immediately.
Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.
Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.
Boston Scientific recalled 21,000 Coyote Over-the-Wire PTA Balloon Dilation Catheters on December 3, 2025. The recall affects devices that may not properly inflate or deflate, posing a risk during medical procedures. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.
Boston Scientific recalled 172 units of the CXR Preconnect with TENACIO Pump with InhibiZone worldwide. The recall was initiated on 2025-09-11 and remains active as of 2025-10-22. The devices can experience inflation and/or deflation performance issues. Healthcare providers should stop using the devices and follow manufacturer instructions for recall remediation.