Boston Scientific Recalls HOT AXIOS Stent and Delivery System Over Deployment Failures

What Happened

Boston Scientific Corporation has initiated a voluntary recall of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System. The recall follows an increase in reports regarding stent deployment and expansion difficulties. According to the FDA, the most common foreseeable outcome is a prolongation of the medical procedure to exchange the faulty device for a new one. However, more serious cases where the first flange fails to deploy or expand can lead to a cascade of events requiring additional endoscopic or surgical intervention to remove the stent and close the puncture site.

Which Products Are Affected

The recall specifically involves the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (6mm x 8mm).

• Material Number (UPN): M00553520
• UDI-DI: 8714729904540
• Recall Number: Z-1161-2026
• Quantity: 266 units
• Lot Numbers: The recall affects over 200 specific lots, including 36067957, 36067958, 36067959, 36067960, 36067961, 36099410, 36102139, 36111317, 36111318, 36111319, and many others listed in the official FDA enforcement report.

The distribution of these devices is worldwide, including nationwide distribution in the United States and Puerto Rico, as well as over 50 other countries across Europe, Asia, the Middle East, and the Americas.

What You Should Do

This is a firm-initiated voluntary recall. Healthcare facilities and providers in possession of the affected lots should immediately stop using the devices and follow the instructions provided by Boston Scientific Corporation for the return or exchange of the product. For further inquiries, the recalling firm is located at 100 Boston Scientific Way, Marlborough, MA 01752.

Why This Matters

This recall has been designated as Class I, the most serious classification. Failure of the stent to deploy or expand correctly during a procedure can lead to significant medical complications, potentially requiring invasive surgery to repair puncture sites or remove the malfunctioning device.

Source

Information provided by the FDA.