Angiodynamics recalls Mini Stick Max 4F X 10 CM Stiff sheath hubs due to potential voids causing guidewire blockage during surgery, risking procedure delays.
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 certain Mini Stick Max 4F X 10 CM Stiff sheath hubs because internal voids may prevent guidewires from passing through during surgery, potentially causing procedure delays. This affects medical devices used in vascular procedures.
The sheath hub contains internal voids that can block guidewires during surgical procedures. This may cause delays in surgery as the user needs to exchange the sheath to complete the procedure.
Healthcare professionals using the Mini Stick Max 4F X 10 CM Stiff sheath hubs for vascular procedures are most at risk. The recall applies to specific lot numbers produced by Angiodynamics.
Check for the catalog number 45-751, UDI 15051684022941, or lot numbers 5789981, 5789983, 5791592, 5791595, 5795873, or 5797462. The product is used for percutaneous guidewire introduction into the vascular system.
Verify the catalog number (45-751), UDI (15051684022941), or lot numbers listed in the recall notice.
The sheath hub contains internal voids that may prevent guidewires from passing through during surgery, potentially causing procedure delays.
The recall notice does not specify a remedy, so check the product details to confirm if it is affected and contact Angiodynamics for further instructions.
The recall states a potential risk of procedure delays but does not mention serious injury or death.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1336-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1336-2024 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.
