Angiodynamics recalls MINI STICK MAX 5F X 10 CM surgical sheaths due to potential voids causing guidewire blockage, 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 is recalling its MINI STICK MAX 5F X 10 CM surgical sheaths because internal voids may prevent guidewires from passing through during procedures, potentially causing delays. This could affect surgeons using the device in vascular surgery.
The sheath hub contains internal voids that can block guidewires during vascular surgery. This may require the surgeon to exchange the sheath, causing delays in the procedure. The risk is procedural delay, not immediate injury.
Surgeons and medical professionals using the MINI STICK MAX 5F X 10 CM sheaths for vascular procedures are most at risk. Patients undergoing surgery with this device may experience delayed procedures.
Check for catalog number 45-775, lot numbers 5790680, 5798831, or 5806100, or the UDI 15051684023184 on the device.
Look for catalog number 45-775, lot numbers 5790680, 5798831, or 5806100, or UDI 15051684023184 on the sheath.
The sheath hub contains internal voids that may prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check for the catalog number 45-775, lot numbers 5790680, 5798831, or 5806100, or UDI 15051684023184. If you have these identifiers, contact Angiodynamics for guidance.
The recall addresses potential procedural delays, not direct injury risks. The hazard is a possible need to exchange the sheath during surgery.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1346-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1346-2024 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.
