Angiodynamics recalls Mini Stick Max 5F X 10 CM sheaths due to potential voids in the hub that could delay surgical procedures. 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 sheaths because they may have voids in the hub that prevent guidewires from passing through during surgery. This could delay procedures and require exchanging the sheath.
The sheath hub may have internal voids that block guidewires from passing through during surgery. This could cause delays in procedures and may require exchanging the sheath to complete the case.
Surgical teams using the Mini Stick Max 5F X 10 CM sheaths for guidewire insertion are most at risk. Patients undergoing procedures requiring this device may be affected.
Check for catalog number 45-774 or lot numbers 5787804, 5787805, 5800397, 5803524, 5805070, 5805071 on the product packaging.
Look for catalog number 45-774 or lot numbers 5787804, 5787805, 5800397, 5803524, 5805070, 5805071 on the product packaging.
The sheath hub may have internal voids that prevent guidewires from passing through during surgery, potentially causing delays in procedures.
Check the product packaging for catalog number 45-774 or lot numbers 5787804, 5787805, 5800397, 5803524, 5805070, or 5805071. If you have these, contact Angiodynamics for guidance.
The recall states the risk is a delay in procedure, not direct injury. The hazard does not mention a risk of serious injury.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1345-2024 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.
