Class 2 Device Recall Angiodynamics

• Date Initiated by Firm: January 30, 2024
• Date Posted: March 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1334-2024
• Recall Event ID: 94035
• 510(K)Number: K132713
• Product Classification: Dilator, vessel, for percutaneous catheterization - Product Code DRE
• Product: MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.; Catalog Number: 45-749
• Code Information: UDI: 15051684022927 UPN: H965457491 Lot Number: 5805056
• Recalling Firm/ Manufacturer: Angiodynamics, Inc.; 603 Queensbury Ave; Queensbury NY 12804-7619
• For Additional Information Contact: SAME; 518-798-1215
• Manufacturer 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
• FDA Determined Cause: Process control
• Action: AngioDynamics initiated Urgent Voluntary Medical Device Recall Notification packets by Federal Express to consignees on 1/30/24. Letter states reason for recall, health risk and action to take: IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Mark affected items with text QUARANTINE to segregate from usable stock. o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. o Notify Healthcare Providers of this possible issue that could occur during use of the Mini Stick Max device. 2. Complete and return the Reply Verification Tracking Form. " If you have any questions regarding this notice and/or if affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. ¿ Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com ¿ Fax Reply Verification Tracking Form: Attn: Mini Stick Max Recall Coordinator Fax number 1-855-273-0519 3. Package and Return the Recalled Product. " Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Mini Stick Max Recall Coordinator
• Quantity in Commerce: 104 units
• Distribution: Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRE and Original Applicant = NAVILYST MEDICAL, INC.