CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Visualase Cooled Laser Applicator System Tubing Set kits recalled
Medtronic Navigation is recalling Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: Vclas 9735559, distributed in 37 states. The recall was initiated on 8 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1905-2020
- FDA event ID
- 85354
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2019
- FDA classified
- 5 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jul 2019 | Recall initiated by company | |
| 5 May 2020 | Classified by FDA | +302 days |
| 13 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth Carolina
Questions about this recall
Is Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: Vclas 9735559 recalled?
Yes. Medtronic Navigation recalled Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: Vclas 9735559 on 8 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-1905-2020.
Why was it recalled?
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.
Which lots are affected?
All kits with lot numbers from 0211041602 through 0217695790
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Navigation
All 92| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation | Medtronic Navigation | Sterility | Nationwide |
| Device | CLASS II | StealthStation S8 App versions 3.0 and 3.2 recalled | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS I | Stealth S8 Clinical recalled by Medtronic Navigation | Medtronic Navigation | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled | Medtronic Navigation | Sterility | Nationwide |
| Device | CLASS II | Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled | Medtronic Navigation | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |