Angiodynamics recalls Mini Stick Max 4F X 10 CM Stiff sheath hubs due to potential delays in surgical procedures if guidewires cannot pass through the introducer hub.
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 recalls certain Mini Stick Max 4F X 10 CM Stiff sheath hubs because voids in the hub may prevent guidewires from passing during surgery, risking procedure delays. This could affect surgeons using these devices in vascular procedures.
The sheath hub contains voids that can prevent guidewires from passing through during surgery. This may cause delays in the procedure, requiring the surgeon to exchange the sheath hub to complete the case.
Surgeons and medical professionals using the Mini Stick Max 4F X 10 CM Stiff sheath hubs for vascular procedures are most at risk. Patients undergoing surgery with these devices may experience delayed procedures.
Check for the catalog number 45-762 or lot numbers 5788541, 5789982, 5791594, 5794608, 5797468, 5798845 on the device. The product is used for percutaneous introduction of guidewires into the vascular system.
Verify the catalog number 45-762 or lot numbers listed on the device to confirm if it is recalled.
The sheath hub may have voids that prevent guidewires from passing through during surgery, potentially causing procedure delays.
The official recall notice does not specify a remedy or action steps for affected users.
The recall states a risk of procedure delays, but does not mention serious injury or death.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1342-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1342-2024 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.
