The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1146-2018·Announced 2018-03-28

Vascular Insights Recalls ClariVein IC Infusion Catheters Due to Manufacturing Defect

Vascular Insights is recalling 928 ClariVein IC infusion catheters because a manufacturing defect may cause the catheter shaft to delaminate.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could cause harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Vascular Insights, LLC is recalling 928 units of the ClariVein IC infusion catheter, Model Number 65-018-E4S. The recall is due to a manufacturing defect that could compromise the catheter shaft, potentially resulting in delamination. This issue may occur during the introduction of the catheter into a vascular access introducer.

The affected devices are identified by Lot number BM651403017I. These catheters were distributed nationwide in the United States, specifically in the states of Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington.

The ClariVein IC infusion catheter is indicated for the infusion of physician-specified agents into the peripheral vasculature. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
Manufacturer
Vascular Insights, LLC
Category
Medical Device — Infusion Catheter
Hazard
Affected units
928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number: BM651403017I

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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