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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 12
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
Part of a larger recall action
This product is one of 14 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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