Angiodynamics recalls Mini Stick Max 4F X 10CM Stiff sheaths due to potential voids causing guidewire blockage during vascular procedures, 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 certain Mini Stick Max 4F X 10CM Stiff sheaths because internal voids may prevent guidewires from passing through during surgery. This could delay procedures and require exchanging the sheath, which might impact patient care.
The sheath hub contains internal voids that can block guidewires during vascular procedures. This may cause procedure delays, requiring the surgical team to exchange the sheath, which could impact patient care timelines.
Surgical teams using the Mini Stick Max 4F X 10CM Stiff sheaths for vascular procedures are most at risk. Patients undergoing such procedures may face delays if the sheath fails to allow guidewire passage.
Check for catalog number 45-781, UDI 15051684023238, or lot numbers 5791593, 5794613, 5797470. The product is used for percutaneous guidewire introduction into the vascular system.
Verify your sheath has catalog number 45-781, UDI 15051684023238, or lot numbers 5791593, 5794613, or 5797470.
The sheath hub contains internal voids that may prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check if your sheath has catalog number 45-781, UDI 15051684023238, or lot numbers 5791593, 5794613, or 5797470. If so, contact Angiodynamics for guidance.
The recall addresses potential procedure delays, not direct injury risk. The hazard is specific to surgical workflow interruptions.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1348-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1348-2024 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.
