Angiodynamics recalls Soft-Vu Angiographic Catheter (model SOFT-VU BER 4F X 65CM 038 NB 0SH) due to a defect preventing proper guidewire passage. This could cause complications during medical procedures.
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 is used improperly.
The catheter hub's inner diameter may be too small for the intended guidewire size, causing the wire to get stuck. This could lead to complications like blockages or the need for additional procedures if the catheter is used during medical treatments.
Healthcare professionals using the Soft-Vu Angiographic Catheter for medical procedures are most at risk if the defect prevents proper guidewire passage during treatment.
Check for the model number SOFT-VU BER 4F X 65CM 038 NB 0SH on the catheter packaging or label. The product was sold with catalog number 10714009 and lot numbers A2825134, A2825153, or A3825063.
Verify the model number and lot numbers on the catheter packaging to confirm if it is affected.
The recall indicates a potential issue that could cause complications during medical procedures, but the risk is low if the catheter is used correctly.
Look for the model number SOFT-VU BER 4F X 65CM 038 NB 0SH on the packaging or label, and check the lot numbers A2825134, A2825153, or A3825063.
The recall does not specify a remedy, so contact Angiodynamics directly for guidance on next steps.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1860-2026 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1860-2026 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.