Z-1146-2018Class II

ClariVein IC infusion catheter, Model Number: 65-018-E4S

Name: Z-1146-2018 ClariVein IC infusion catheter, Model Number: 65-018-E4S
Creator: Vascular Insights, LLC
Published: 2017-11-09
License: https://open.fda.gov/license/

Vascular Insights, LLC / initiated 2017-11-09 / Terminated / root cause: manufacturing process

FDA source

Vascular Insights, LLC began a recall of ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified... on 2017-11-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1146-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Posted: 2018-03-21
Terminated: 2018-12-18
Recalling firm: Vascular Insights, LLC
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.
Product code: KRA Catheter, Continuous Flush
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vascular Insights sent an Urgent Voluntary Medical Device Recall letter to their customers. The letter identified the affected product, problem and the actions to be taken. Customers were instructed to 1. Do not use or distribute any recalled product. 2. Immediately remove all recalled product from your inventory. 3. Segregate recalled product in a secure location and follow the instruction herein to return the recalled product and receive replacement product. 4. Immediately forward a copy of this recall notification to any/all sites to which you may have distributed the affected product and provide directions to follow the instructions contained herein. Customers were asked to complete and return the enclosed Reply Verification Tracking Form.
Quantity in commerce: 928
Distribution: 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
Product codes and lots: Lot number: BM651403017I

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-20

Product code KRA

K071468Class IIClarivein CatheterVascular Insights, LLC / cleared 2008-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)