Angiodynamics recalls Mini Stick Max 5F X 10 CM sheaths due to potential voids causing guidewire blockage during surgery, risking procedure delays. Affected units have specific 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 5F X 10 CM sheaths because they may have internal voids that prevent guidewires from passing through during surgery. This could cause delays in procedures and might require exchanging the sheath.
The sheaths may have internal voids that block guidewires during surgical procedures. This could cause delays in surgery and might require exchanging the sheath to complete the procedure.
Surgical teams using the Mini Stick Max 5F X 10 CM sheaths for guidewire introduction are affected. Those with specific lot numbers from the recall list are most at risk.
Check for the model 'Mini Stick Max 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-' on the product. Affected units have lot numbers 5790681, 5795961, 5800479, 5803518, or 5805067.
Verify the model number and lot numbers listed in the recall notice to confirm if your sheath is affected.
The sheaths may have internal voids that prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check the lot numbers listed in the recall notice to see if your sheath is affected. If it is, contact Angiodynamics for guidance.
The recall notice does not specify a fix or remedy; affected users should check if their sheath is in the list and contact the manufacturer.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1343-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1343-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
