Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1341-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 30, 2024

Date Posted: March 27, 2024

Recall Number: Z-1341-2024

Event ID: 94035

Reason for Recall:

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

Status: Ongoing

Product Quantity: 5840 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated