Angiodynamics recalls Soft-Vu HH1 catheters with a defect that may prevent guidewires from passing through the hub, risking procedure failure. Affected units have specific model numbers and catalog codes.
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Angiodynamics is recalling Soft-Vu Angiographic Catheters with a manufacturing defect that could prevent properly sized guidewires from passing through the catheter hub. This risk may cause procedure failure during medical imaging procedures.
The catheter hub's inner diameter may be too small for the correct guidewire size due to a manufacturing defect. This could cause the guidewire to get stuck, potentially leading to procedure failure or complications during medical imaging.
Medical professionals using the Soft-Vu HH1 catheters for angiography procedures are most at risk. Patients receiving these procedures may be affected if the catheter fails during treatment.
Check for the model number SOFT-VU HH1 4F X 100CM 038 NB 0SH with catalog number 10714040. The product comes in boxes with 5 pouches each and has specific lot numbers.
Verify the model number and catalog code on the product packaging to confirm if it's affected.
The affected catheters have a manufacturing defect that may prevent the appropriately sized guidewire from passing through the inner diameter of the hub.
The official recall notice does not specify a remedy or action for affected products.
Check for the model number SOFT-VU HH1 4F X 100CM 038 NB 0SH with catalog number 10714040 on the packaging.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1868-2026 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1868-2026 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.
