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Recall Observatory FDA recall evidence

Device product

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

Z-1032-2025

December 20, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 96049
Status
Ongoing
Classification
Class II
Quantity
263 units (OUS)
Official record key
device-enforcement:Z-1032-2025

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: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272

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.