Angiodynamics recalls Mini Stick Max 4F X 10 CM sheaths due to potential voids in the hub that may prevent guidewire passage during surgery, causing procedure delays.
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 in the hub could prevent guidewires from passing through during surgery, potentially causing procedure delays. This affects medical devices used in vascular procedures.
The sheath hub contains voids that may prevent the guidewire from passing through during surgery. This could lead to procedure delays as the user may need to exchange the sheath to complete the case.
Healthcare professionals using the Mini Stick Max 4F X 10 CM sheaths for vascular procedures are most at risk. The recall affects specific lot numbers of these medical devices.
Check for the product name 'Mini Stick Max 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG' on the device. The affected lot numbers include 5784035 through 5806116 as listed in the recall notice.
Look for the lot numbers listed in the recall: 5784035 through 5806116.
The sheath hub may have voids that prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check the lot number on your device. If it matches the listed numbers (5784035 through 5806116), contact Angiodynamics for further instructions.
The recall states the risk is a potential delay in procedure, not serious injury. The hazard does not involve immediate safety risks like fire or laceration.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1335-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1335-2024 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.
