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Recall Observatory FDA recall evidence

Device 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.

Z-1146-2018

November 09, 2017

Class II

Product summary

Firm
Vascular Insights, LLC
Event
Event 79324
Status
Terminated
Classification
Class II
Quantity
928
Official record key
device-enforcement:Z-1146-2018

Official wording

Reason: 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.

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect