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Recall Observatory FDA recall evidence

Device product

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Z-1027-2025

December 20, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 96049
Status
Ongoing
Classification
Class II
Quantity
309 units
Official record key
device-enforcement:Z-1027-2025

Official wording

Reason: 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.

Code information: GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296

Distribution pattern: Nationwide including Puerto Rico Foreign: To be provided

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.