Angiodynamics recalls Mini Stick Max 5F X 10 CM sheaths due to potential voids in the hub that could delay surgical procedures. 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 its Mini Stick Max 5F X 10 CM sheaths because they may have voids in the hub that prevent guidewires from passing through during surgery. This could delay procedures and require exchanging the sheath.
The sheath hub may contain voids that block the guidewire from passing through. This could cause delays in surgery, requiring the team to exchange the sheath to complete the procedure.
Surgical teams using the Mini Stick Max 5F X 10 CM sheaths for guidewire introduction are most at risk. Patients undergoing procedures requiring these sheaths may face delays.
Check for the catalog number 45-767 or lot numbers 5787806, 5790679, 5795962, 5803521, 5806728. The product is used for percutaneous guidewire introduction in vascular procedures.
Verify the catalog number (45-767) or lot numbers listed in the recall notice.
The sheath hub may have voids that prevent guidewires from passing through during surgery, potentially causing delays.
Check the catalog number or lot numbers to see if your unit is affected; contact Angiodynamics for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1344-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1344-2024 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.
