PlainRecalls
FDA Devices Moderate Class II Ongoing

MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775

Reported: March 27, 2024 Initiated: January 30, 2024 #Z-1346-2024

Product Description

MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775

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

Details

Recalling Firm
Angiodynamics, Inc.
Units Affected
65 units
Distribution
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Location
Queensbury, NY

Frequently Asked Questions

What product was recalled?
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775. Recalled by Angiodynamics, Inc.. Units affected: 65 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1346-2024.