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Recall Observatory FDA recall evidence

Device product

MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

Z-1341-2024

January 30, 2024

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 94035
Status
Ongoing
Classification
Class II
Quantity
5840 units
Official record key
device-enforcement:Z-1341-2024

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: 15051684023023 UPN: H965457591 Lot Number: 5789493 5789494 5789495 5789496 5789497 5791596 5791597 5791598 5793392 5793393 5794602 5794603 5794604 5794605 5794606 5795874 5795875 5797457 5797458 5797466 5797467 5798837 5798843 5798844

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