The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1025-2025·Announced 2025-02-05

AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion

Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.

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 involving a mechanical defect in a stent delivery system. The outer sheath detachment is a real, observed malfunction that prevents proper device function. No injuries or deaths have been reported, placing this in the High severity category for risk-of-harm products without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm, UPN: M00553650) due to a potential defect. Approximately 1,144 units have been distributed nationwide in the United States, including Puerto Rico, and 60 units internationally.

The outer sheath's distal black tip can detach from the device during use. If this occurs, the separated tip may remain around the stent saddle, preventing the stent from expanding properly during the procedure.

When this defect occurs, physicians must extend the procedure to remove the malfunctioning device and exchange it for a new one. Healthcare facilities that may have received devices from the affected lot numbers should verify their inventory and follow Boston Scientific's instructions regarding management and replacement of recalled units.

The recalled product

Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Stent Delivery System
Hazard

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 (20)

  • GTIN: 08714729904595 Lot Numbers: 32891503
  • 32946481
  • 32966087
  • 32976911
  • 32986912
  • 32986913
  • 32986914
  • 32996152
  • 33004776
  • 33004777
  • 33004779
  • 33008425
  • 33527176
  • 33547873
  • 33559652
  • 33562171
  • 33568700
  • 33568705
  • 33568709
  • 33580106

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 14 products in this recall →

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