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Recall Observatory FDA recall evidence

Device product

MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

Z-1348-2024

January 30, 2024

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 94035
Status
Ongoing
Classification
Class II
Quantity
39 units
Official record key
device-enforcement:Z-1348-2024

Official wording

Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

Code information: UDI: 15051684023238 UPN: H965457811 Lot Number: 5791593 5794613 5797470

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case