Angiodynamics recalls Mini Stick Max 5F X 15 CM Stiff sheaths due to potential procedure delays from guidewire passage issues. 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 15 CM Stiff sheaths because they may prevent guidewires from passing through during surgery, risking procedure delays. This could affect surgeons using these devices in vascular procedures.
The sheath hub contains voids that can block guidewires during surgical procedures. This may require the surgeon to exchange the sheath, causing delays in the procedure. The delay could impact patient care and surgical outcomes.
Surgeons and medical professionals using the Mini Stick Max 5F X 15 CM Stiff sheaths for vascular procedures are most at risk. Patients undergoing surgery with these devices may experience delayed procedures.
Check for the catalog number 45-776, UDI 15051684023191, or lot numbers 5787840, 5803520, 5805069 on the device. The sheath is labeled as 'MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75"'.
Look for the catalog number 45-776, UDI 15051684023191, or lot numbers 5787840, 5803520, 5805069 on the sheath.
The sheath hub may have voids that prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check for the catalog number 45-776, UDI 15051684023191, or lot numbers 5787840, 5803520, 5805069. If you have these details, contact Angiodynamics for guidance.
The recall addresses potential procedure delays, not direct injury risks. The hazard does not mention injury.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1347-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1347-2024 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.
