Angiodynamics recalls Mini Stick Max 4F X 10 CM sheaths due to potential voids causing guidewire blockage, risking surgical 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 4F X 10 CM sheaths because internal voids might prevent guidewires from passing through during surgery. This could cause delays in procedures, requiring a sheath exchange.
The sheath hub contains internal voids that can block guidewires from passing through. This may cause surgical delays, requiring a sheath exchange to complete the procedure.
Surgical teams using the Mini Stick Max 4F X 10 CM sheaths for guidewire introduction during vascular procedures are most at risk. Patients undergoing such surgeries may face procedural delays.
Check for catalog number 45-749 or lot number 5805056 on the sheath packaging. The product is used for percutaneous guidewire introduction in vascular procedures.
Inspect the sheath hub for internal voids that may block guidewires during use.
Reach out to Angiodynamics for specific instructions on whether the sheath needs replacement.
The sheath hub may have internal voids that prevent guidewires from passing through during surgery, potentially causing procedural delays.
Check for catalog number 45-749 or lot number 5805056. Contact Angiodynamics for guidance on whether replacement is needed.
The recall addresses potential procedural delays, not direct injury risks. The hazard is specific to surgical use cases.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1334-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1334-2024 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.
