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Mini Stick MAX recallZ-1341-2024 · Angiodynamics, Inc. · initiated Jan 30, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Process control

What the company is doing

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): [email protected] 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

Recall details

Recall number
Z-1341-2024
Status
Open, Classified
Initiated by the company
Jan 30, 2024
Posted by the FDA
Mar 21, 2024
Recalling firm
Angiodynamics, Inc.
Quantity
5840 units
Product code
DRE
FDA submissions
K132713
Distribution
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.

Product description

MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

Code information (models, lots, serial numbers)

UDI: 15051684023023 UPN: H965457591 Lot Number: 5789493 5789494 5789495 5789496 5789497 5791596 5791597 5791598 5793392 5793393 5794602 5794603 5794604 5794605 5794606 5795874 5795875 5797457 5797458 5797466 5797467 5798837 5798843 5798844

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

23 devices cleared under K132713 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94035).

Sources and updates

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