The Recall Desk
HighFDA (Devices)·Z-1030-2025·Announced 2025-02-05

AXIOS Stent and Delivery System Recalled for Improper Expansion Risk

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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. It qualifies as a risk-of-harm product where injury has not yet been reported, as the device malfunction could compromise patient treatment, though no adverse outcomes have been documented.

Plain-English summary

Boston Scientific Corporation is recalling the AXIOS Stent and Delivery System 10mmx10mm (UPN: M00553740) due to a manufacturing defect. The affected lot number is 34477280 (GTIN: 08714729904625), affecting 12 units distributed nationwide including Puerto Rico.

The outer sheath distal black tip of the device can detach during use. When the black tip detaches, it remains around the stent saddle and prevents proper stent expansion. This defect requires the device to be exchanged for a new one during the procedure, which prolongs the operation.

Affected devices can be identified by lot number 34477280.

The recalled product

Product
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Stent System
Hazard
  • device-malfunction
  • improper-expansion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 08714729904625 Lot Numbers: 34477280

Distribution

Distributed nationwide across the United States.

Related recalls

Same category