Angiodynamics recalls Mini Stick Max 5F X 10 CM surgical sheaths due to potential guidewire blockage during procedures, risking delays in surgery. 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 is recalling certain Mini Stick Max 5F X 10 CM surgical sheaths because they may prevent the guidewire from passing through the hub during surgery. This could cause delays in procedures, requiring the surgeon to exchange the sheath.
The sheath hub has internal voids that can prevent the guidewire from passing through during surgery. This may cause delays in the procedure, requiring the surgeon to exchange the sheath to complete the case.
Surgeons and medical staff using the Mini Stick Max 5F X 10 CM sheaths for procedures. Those with the specific catalog number 45-756 and listed lot numbers are most at risk.
Check for the catalog number 45-756 and lot numbers 5796084 through 5799620, 5800404, 5803526, or 5804396 on the product label.
Look for the catalog number 45-756 and lot numbers listed in the recall notice.
The sheath hub has internal voids that may prevent the guidewire from passing through during surgery, causing potential delays in procedures.
Check the product label for the catalog number 45-756 and lot numbers listed in the recall notice. If you have the affected units, contact Angiodynamics for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1339-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1339-2024 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.
