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Health Canada Medical devices

Mini-Stick Max Coaxial Microintroducer Kit

Issued February 9, 2024
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
Hazard description
Performance
Product
Product name
Mini-Stick Max Coaxial Microintroducer Kit
Reference
ID
RA-75056