Recall Z-1345-2024— Angiodynamics, Inc.

Name: FDA recall Z-1345-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-30

Class II · Ongoing

Class II FDA medical device recall by Angiodynamics, Inc., initiated 2024-01-30. It names one FDA 510(k) clearance: K132713. Product: MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774. 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.

Recalling firm: Angiodynamics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-30
Firm location: Queensbury, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K132713 — NMI COAXIAL MICROINTRODUCER SETNavilyst Medical, Inc.·cleared 2013-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.