Medtronic Visualase Cooled Laser Applicator Tip Recall: Saline Leak Risk
Medtronic recalls specific VCLAS 15MM TIP models due to potential saline leaks from improper sealing. Affected units may require replacement to prevent complications during medical procedures.
Lower-risk recall
Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
Contact the company
What happened, in plain English
Medtronic is recalling certain VCLAS 15MM TIP components because they might not seal properly, causing saline to leak. This could lead to complications during medical procedures if the device is used without the seal. Read more at govinfonow.com/recall/73915-medtronic-visualase-cooled-laser-applicator-tip-recall-saline-leak-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73915-medtronic-visualase-cooled-laser-applicator-tip-recall-saline-leak-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2755-2017
Cite this page
“Medtronic Visualase Cooled Laser Applicator Tip Recall: Saline Leak Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73915-medtronic-visualase-cooled-laser-applicator-tip-recall-saline-leak-risk. Based on FDA recall #Z-2755-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2755-2017%22&limit=1).
Why it’s dangerous
The VCLAS 15MM TIP cap (Tuohy Borst Adapter) may not create a proper seal around the optical fiber. This can cause saline to leak out, potentially leading to complications during medical procedures where precise fluid control is critical.
Who’s affected
Patients undergoing medical procedures using the recalled VCLAS 15MM TIP components are most at risk. Healthcare providers using these specific parts for laser surgery may also be affected.
How to tell if you have this one
Check for the VCLAS 15MM TIP with reference number 9735561 and lot numbers listed in the recall notice. The product includes a laser diffusing fiber (600um) and cooling catheter components.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Details
Review the product's reference number and lot numbers to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Minnesota, New York, Texas.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall indicates a potential for saline leaks, but no specific serious injury risk is mentioned in the notice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2755-2017 (June 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2755-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.