Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1348-2024)

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 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

Product Classification:

Class II

Date Initiated: January 30, 2024
Date Posted: March 27, 2024
Recall Number: Z-1348-2024
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: 39 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated