Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1024-2025·Announced 2025-02-05

AXIOS Stent Delivery System Outer Sheath May Detach During Deployment

Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with a confirmed mechanical defect in the delivery system that prevents proper stent expansion. The defect is detected during the procedure and managed through device exchange, with no reported injuries or hospitalizations.

Plain-English summary

Boston Scientific Corporation is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm) due to a defect in the device's outer sheath. During the procedure, the distal black tip of the sheath can detach from the device and remain around the stent saddle, preventing proper stent expansion.

When the outer sheath detaches, the healthcare provider must exchange the affected device for a new one, which significantly extends the procedure duration. The recall affects 495 units distributed in the United States, including Puerto Rico, and 2 units distributed internationally, with 41 specific lot numbers identified.

The recalled product

Product: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Stent Delivery System
Hazard: sheath-detachment
stent-expansion-failure

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: 08714729904588 Lot Numbers: 32891042
32900457
32908438
33215358
33215359
33216060
33216062
33219660
33219662
33219663
33315967
33315970
33324398
33500190
33520871
33520872
33537659
33538481
33538484
33559005

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 →

Same manufacturer · Boston Scientific Corporation

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Same hazard · sheath detachment