Angiodynamics recalls MINI STICK MAX 4F catheters due to potential guidewire blockage during surgery, 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 recalls its MINI STICK MAX 4F catheters because voids in the sheath hub may prevent guidewires from passing during surgery, causing procedure delays. This could lead to needing to exchange the catheter mid-surgery.
The catheter's sheath hub has internal voids that can block guidewires during surgery. This may cause procedure delays, requiring the surgeon to exchange the catheter mid-surgery to complete the procedure.
Surgical teams using the MINI STICK MAX 4F catheters for guidewire introduction are most at risk. Patients undergoing procedures with this specific catheter model may experience delays.
Check for catalog number 45-752 or lot numbers 5805057/5806119 on the catheter packaging. The product is used for percutaneous guidewire introduction in vascular procedures.
If the guidewire does not pass through the catheter hub during surgery, stop using it immediately and contact your surgeon.
The catheter's sheath hub has internal voids that may prevent guidewires from passing during surgery, causing procedure delays.
Check the catalog number (45-752) or lot numbers (5805057/5806119) on the packaging. If you have the affected model, contact your surgeon about potential procedure delays.
The recall does not provide a fix; surgeons may need to exchange the catheter mid-surgery if guidewires block.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1337-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1337-2024 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.
