Who should I contact about this recall?

Contact Boston Scientific Corporation directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Boston Scientific Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation, including 272 recalls and 0 warning letters.

FDA Class II Recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 by Boston Scientific Corporation

Key facts

Recalling firm	Boston Scientific Corporation
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
Classification	Class II
Recall number	Z-1031-2025
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

The short version: FDA classified a recall by Boston Scientific Corporation as Class II, reported 20250205. The affected product is AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 (recall number Z-1031-2025). Reason for recall: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.. Status: Ongoing. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Boston Scientific Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Boston Scientific Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Boston Scientific Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Boston Scientific Corporation’s FDA history

Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Boston Scientific Corporation's recall?: FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Why was AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 recalled?: FDA's recall record states the reason as: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Who should I contact about this recall?: Contact Boston Scientific Corporation directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.
Has Boston Scientific Corporation had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation, including 272 recalls and 0 warning letters.

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Full FDA history for Boston Scientific Corporation

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). FDA Class II Recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 by Boston Scientific Corporation — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/boston-scientific-corporation-z-1031-2025-2025-02-05

MLA

"FDA Class II Recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 by Boston Scientific Corporation — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/recall/boston-scientific-corporation-z-1031-2025-2025-02-05.

Chicago

Argus HQ Research. "FDA Class II Recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 by Boston Scientific Corporation — Recall Details." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/boston-scientific-corporation-z-1031-2025-2025-02-05.

BibTeX

@misc{argushq_argushq_ai_recall_boston_scientific_corporation_z_1031_2025_2025_02_05_2025,
  title = {FDA Class II Recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 by Boston Scientific Corporation — Recall Details},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/boston-scientific-corporation-z-1031-2025-2025-02-05},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov — Recalls ↗