Vascular Insights, LLC: Medical Device Recall in 2018 - (Recall #: Z-1146-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 9, 2017

Date Posted: March 28, 2018

Recall Number: Z-1146-2018

Event ID: 79324

Reason for Recall:

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.

Status: Terminated

Product Quantity: 928

Code Information:

Lot number: BM651403017I

Distribution Pattern:

U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA

Voluntary or Mandated:

Voluntary: Firm initiated