Vascular Solutions recalls Langston Dual Lumen Catheter 6F Model 5540 for risk of inner lumen separating from hub during pressure injection. Affected units have specific lot numbers and UDI codes.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Vascular Solutions is recalling its Langston Dual Lumen Catheter 6F Model 5540 due to a risk that the inner lumen may separate from the hub during pressure injection. This could lead to improper contrast medium delivery during medical procedures.
During pressure injection of contrast medium, the inner lumen of the catheter may separate from the hub. This could cause improper delivery of contrast, potentially leading to complications during medical imaging procedures.
Healthcare professionals using this catheter for angiographic studies are most at risk. Patients receiving procedures with this model may be affected if the catheter is used.
Check for the model number 5540 on the catheter. Affected units have specific lot numbers listed in the recall notice and a unique device identifier (UDI) of 10841156100513.
Identify the model number and lot numbers listed in the recall notice to confirm if your catheter is affected.
The recall indicates a potential risk during pressure injection, so affected units should not be used until replaced.
Contact Vascular Solutions directly to confirm if your specific unit is affected and follow their instructions.
Check for the model number 5540 and the specific lot numbers listed in the recall notice (e.g., 651278, 651457).
We’ve drafted a message you can send Vascular Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1747-2020 — Vascular Solutions Vascular Solutions Hello, I own a Vascular Solutions that is covered by recall Z-1747-2020 from Vascular Solutions. 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.
