Vascular Insights recalls ClariVein IC infusion catheters (model 65-018-E4S) due to potential shaft delamination during vascular access. Affected units may require replacement to prevent complications.
Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
Vascular Insights is recalling ClariVein IC infusion catheters with model number 65-018-E4S because a manufacturing defect could cause the catheter shaft to delaminate during insertion into a vascular access device. This poses a risk of complications during medical procedures.
A manufacturing defect in the catheter shaft could cause layers to separate (delamination) during insertion into a vascular access device. This might lead to complications like blockages or improper function during medical procedures.
Healthcare professionals using the ClariVein IC catheter for medical procedures are most at risk. Patients receiving infusion treatments with this specific model may also be affected.
Check for the model number 65-018-E4S on the catheter packaging or label. The product was sold with lot number BM651403017I.
Look for the model number 65-018-E4S on the catheter packaging or label.
Reach out to Vascular Insights for guidance on next steps if you have the recalled model.
The recall indicates a potential risk of shaft delamination during insertion, so it is not recommended for use until the manufacturer provides guidance.
Contact Vascular Insights directly to discuss next steps for the recalled model 65-018-E4S.
The recall record does not specify a fix or remedy; the manufacturer is being contacted for guidance.
We’ve drafted a message you can send Vascular Insights to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2018 — Vascular Insights Vascular Insights Hello, I own a Vascular Insights that is covered by recall Z-1146-2018 from Vascular Insights. 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.
