Angiodynamics recalls Mini Stick Max 5F X 10 CM Stiff sheath hubs due to potential voids causing guidewire blockage, 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 is recalling certain Mini Stick Max 5F X 10 CM Stiff sheath hubs because internal voids may prevent guidewires from passing through during surgery. This could delay procedures and require exchanging the sheath, which might affect surgical outcomes.
The sheath hub contains internal voids that can block the guidewire from passing through during a procedure. This may cause delays in surgery, requiring the team to exchange the sheath to complete the case, which could impact patient care.
Surgical teams using the Mini Stick Max 5F X 10 CM Stiff sheath hubs for guidewire introduction are most at risk. The recall affects specific units with catalog numbers starting with 45-759 and certain lot numbers.
Check for the catalog number 45-759 and lot numbers listed in the recall (5789493 through 5798844). The product is used for percutaneous guidewire introduction in vascular procedures.
Verify the catalog number (45-759) and lot numbers (5789493-5798844) to confirm if your unit is affected.
The sheath hub may have internal voids that prevent guidewires from passing through during surgery, potentially causing procedure delays.
Check the catalog number (45-759) and lot numbers (5789493-5798844) to see if your unit is affected. If affected, contact Angiodynamics for guidance.
The recall does not specify a fix; affected units may need to be exchanged by the surgical team if the issue occurs during a procedure.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1341-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1341-2024 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.
