FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
- Recall number
- Z-1905-2020
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
- Status
- Terminated
- Initiated
- 2019-07-08
- Posted
- not on file
- Terminated
- 2024-10-16
- Reason
- The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
- Root cause
- Nonconforming Material/Component
- Action
- The firm issued its first customer notification and customer response form on 7/8/2019. On 7/16/2019, a second notification was issued to allow customers to identify recalled product by lot number. On 10/3/2019, the firm issued a third customer notification to include three additional affected lots. The firm requested customers examine inventory for affected lot numbers and quarantine for return to the firm and to complete the attached customer response form.
- Quantity
- 4654 units
- Distribution
- US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK
- Lot, serial or model codes
- All kits with lot numbers from 0211041602 through 0217695790
- 510(k) numbers
- ["K071328"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- 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