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Recall Observatory FDA recall evidence

Device product

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

Z-1033-2025

December 20, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 96049
Status
Ongoing
Classification
Class II
Quantity
91 units (OUS)
Official record key
device-enforcement:Z-1033-2025

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: 08714729904557 Lot Numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, 34101926

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.