Angiodynamics, Inc. 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Angiodynamics, Inc.
Lot Codes / Batch Numbers
UDI: 15051684022927 UPN: H965457491 Lot Number: 5805056
Products Sold
UDI: 15051684022927 UPN: H965457491 Lot Number: 5805056
Angiodynamics, Inc. is recalling MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a g due to Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026