Z-1034-2025Class II

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Name: Z-1034-2025 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Creator: Boston Scientific Corporation
Published: 2024-12-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540 on 2024-12-20. FDA classified it as Class II and gives 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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1034-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-20
Posted: 2025-01-29
Recalling firm: Boston Scientific Corporation
Product: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.
Quantity in commerce: 519 units (OUS)
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Product codes and lots: GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1034-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1024-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1025-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1026-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1027-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1028-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1029-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1030-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1031-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1032-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1033-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1034-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1035-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1036-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30
Z-1037-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-05	2025-01-30

Product code KNS

K233318Class IIAXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)Boston Scientific Corporation / cleared 2023-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)