Angiodynamics recalls Mini Stick Max 5F X 10 CM Stiff sheath hubs due to potential guidewire blockage during surgery, risking procedure delays. Affected units have specific catalog and lot numbers.
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
Angiodynamics recalls a specific surgical sheath hub model because it may prevent guidewires from passing through during procedures, causing delays. This could lead to extended surgery times or needing to replace the sheath.
The sheath hub contains internal voids that can block guidewires during surgical procedures. This may cause delays in surgery, requiring the team to exchange the sheath to complete the procedure.
Surgical teams using this specific sheath hub model for guidewire introduction during vascular procedures. Patients and staff at medical facilities using the recalled product are most at risk.
Check for the catalog number 45-758 or lot number 5805060 on the product. The product is labeled as 'MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG' for percutaneous guidewire introduction.
Verify the catalog number (45-758) or lot number (5805060) on the sheath hub.
The product may cause guidewire blockage during surgery, leading to procedure delays. It is not safe to use without checking for the recall.
Look for the catalog number 45-758 or lot number 5805060 on the sheath hub.
Check the product details to confirm if it's recalled; if so, contact Angiodynamics for guidance.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1340-2024 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
