CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
Axios Stent and Electrocautery- Enhanced Delivery System recalled
Boston Scientific is recalling Axios Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680, distributed nationwide in the US. The recall was initiated on 20 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1028-2025
- FDA event ID
- 96049
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 30 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 30 Jan 2025 | Classified by FDA | +41 days |
| 5 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Where it was distributed
Nationwide including Puerto Rico Foreign: To be provided
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN: 00191506008086 Lot Numbers: 33457806, 33512838, 34035520
Where was it sold?
Nationwide including Puerto Rico Foreign: To be provided
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 96049This product is part of a recall event; the main page for the event is Axios Stent and Delivery System 10mmx10mm UPN: M00553740 recalled.
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