Medtronic VCLAS Laser Tips Recall: Saline Leakage Risk
Medtronic recalls VCLAS 3mm, 10mm, and 15mm laser tips due to potential saline leakage during manufacturing. Affected units include specific part numbers and lots. Consumers should contact Medtronic for details.
Lower-risk recall
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Contact the company
What happened, in plain English
Medtronic is recalling certain VCLAS laser tips that may have saline leakage issues from improper manufacturing testing. This could lead to complications during medical procedures if the device is used without proper safety checks. Read more at govinfonow.com/recall/73345-medtronic-vclas-laser-tips-recall-saline-leakage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73345-medtronic-vclas-laser-tips-recall-saline-leakage-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0025-2018
Cite this page
“Medtronic VCLAS Laser Tips Recall: Saline Leakage Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73345-medtronic-vclas-laser-tips-recall-saline-leakage-risk. Based on FDA recall #Z-0025-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2018%22&limit=1).
Why it’s dangerous
The tips were not properly tested for saline leakage during manufacturing, which could cause fluid to leak into the patient's body during surgery. This might lead to complications like infection or tissue damage if the device is used without adequate safety checks.
Who’s affected
Patients undergoing medical procedures using the recalled VCLAS laser tips are most at risk. The recall affects specific model numbers and production lots sold to medical facilities.
How to tell if you have this one
Check for part numbers 9735559 (3mm), 9735560 (10mm), or 9735561 (15mm) with specific production lots listed in the recall notice. These tips are used in medical procedures for tissue ablation.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Contact Medtronic
Reach out to Medtronic directly to confirm if your device is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years 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
Do I need to stop using the device immediately?
The recall does not require immediate discontinuation; contact Medtronic to determine if your device is affected and follow their instructions.
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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-0025-2018 (July 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0025-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.