FDA Medical Device Recalls (openFDA)
Vascular Insights, LLC: 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.
- Recall number
- Z-1146-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-11-09
- Posted
- not on file
- Terminated
- 2018-12-18
- 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.
- 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
- 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
- Lot, serial or model codes
- Lot number: BM651403017I
- 510(k) numbers
- ["K071468"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3005831739
- Firm city
- Quincy
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28