The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1026-2025·Announced 2025-02-05

AXIOS stent delivery system outer sheath detachment prevents proper expansion

Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and 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 recall of a medical device with a functional defect that prevents proper expansion, requiring device exchange during the procedure. No injuries or illnesses have been reported in the source text. The device malfunction constitutes a risk-of-harm situation where the problem is identified and corrected during the procedure before patient harm occurs, warranting a High severity rating.

Plain-English summary

Boston Scientific Corporation is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm, UPN: M00553660) due to a defect in the outer sheath. The recall affects 1,399 units distributed nationwide, including Puerto Rico, plus 20 units distributed overseas.

The outer sheath's distal black tip can detach from the device during use. When detachment occurs, the tip can remain lodged around the stent saddle, preventing the stent from expanding properly. This complication requires the physician to prolong the procedure and exchange the affected device for a replacement.

Healthcare facilities that have received affected lots should contact Boston Scientific immediately to arrange device replacement. A complete list of affected lot numbers is available from the FDA. Patients who have already undergone procedures with this device should consult their healthcare provider if they experience any complications.

The recalled product

Product
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
Manufacturer
Boston Scientific Corporation
Category
Medical Device
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: 08714729951179 Lot Numbers: 32913258
  • 32914587
  • 32914588
  • 32914951
  • 32919344
  • 33161778
  • 33167722
  • 33167723
  • 33167724
  • 33168696
  • 33168697
  • 33217106
  • 33217107
  • 33223926
  • 33223927
  • 33224949
  • 33233462
  • 33234152
  • 33235720
  • 33235721

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 →

Related recalls

Same manufacturer · Boston Scientific Corporation

See all →

Same hazard · sheath detachment

See all →

Similar recalls