Health product recall

Mini-Stick Max Coaxial Microintroducer Kit

Last updated

Summary

Product
Mini-Stick Max Coaxial Microintroducer Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Mini-Stick Max Coaxial Microintroducer Kit More than 10 numbers, contact manufacturer. H965457541 H965457591 H965457501 H965457491 H965457511 H965457561

Issue

Angiodynamics, Inc., is conducting a medical device field safety corrective action (FSCA) to the end user level based on the non-conformance of a supplied component included within the Angiodynamics Mini Stick Max Coaxial Microintroducer Kit. This 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.

Recall start date: January 30, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Navilyst Medical, Inc.

26 Forest Street, Marlborough, Massachusetts, United States, 01752

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75056