Angiodynamics recalls Mini Stick Max 5F 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 5F X 10 CM sheaths because they may have voids in the hub that prevent guidewires from passing through during surgery. This could cause delays in medical procedures and might require exchanging the sheath.
The sheaths may have voids in the internal hub that prevent guidewires from passing through during surgery. This could cause procedure delays and might require exchanging the sheath to complete the surgical case.
Surgical teams using the Mini Stick Max 5F X 10 CM sheaths for guidewire insertion are most at risk. Patients undergoing procedures requiring these sheaths could experience delays.
Check for the model number 'MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG' on the sheath. The lot numbers 5784134 through 5803531 are also associated with this recall.
Inspect the sheath hub for voids that might prevent guidewire passage during surgery.
The sheaths may have voids in the internal hub that prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check for voids in the sheath hub; if you suspect a problem, contact Angiodynamics for guidance.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1338-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1338-2024 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.
