Angiodynamics recalls Soft-Vu Angiographic Catheter (Kumpe Non-Braided) due to a defect preventing proper guidewire passage through the catheter hub. 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 a specific type of angiographic catheter because a manufacturing defect might prevent the correct size guidewire from passing through the catheter hub. This could lead to complications during medical procedures if the catheter cannot be properly navigated.
The catheter hub has a manufacturing defect that may prevent the appropriately sized guidewire from passing through its inner diameter. This could cause the catheter to become stuck during medical procedures, potentially leading to complications.
Healthcare professionals using the Soft-Vu Angiographic Catheter for medical procedures are most at risk. Patients receiving these procedures may be affected if the catheter malfunctions.
Check for the model number SOFT-VU KMP 4F X 40CM 038 NB 0SH, catalog number 10710013, or lot numbers A3625012 and A3825055. The product comes in a box with 5 pouches.
Verify the model number, catalog number, and lot numbers to confirm if your catheter is affected.
The recall indicates a potential defect that could prevent proper guidewire passage, so it is not recommended for use until the issue is resolved.
The recall does not specify a remedy, so contact Angiodynamics directly for guidance on next steps.
Check for the model number SOFT-VU KMP 4F X 40CM 038 NB 0SH, catalog number 10710013, or lot numbers A3625012 and A3825055.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1857-2026 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1857-2026 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.