Medtronic recalls Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips due to potential low laser energy output from untested fibers, which could cause fiber burnout at lower wattage.
Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.
Medtronic is recalling specific models of their Visualase Cooled Laser Applicator System (VCLAS) 3mm, 10mm, and 15mm tips because certain batches were not tested at intended laser power levels. This could lead to the laser fibers producing less energy than expected, potentially causing burnout at lower wattage during medical procedures.
Certain lots of the VCLAS laser diffusing fibers were not tested at intended laser power levels due to calibration issues in testing equipment. This could result in the fibers producing lower laser energy than specified, potentially causing burnout at lower wattage during medical procedures.
Medical professionals using the Visualase system for thermal therapy under MRI guidance are most at risk. Patients undergoing procedures with these specific tip models may be affected if their device is part of the recalled lots.
Check for part numbers 9735559 (3mm tip), 9735560 (10mm tip), or 9735561 (15mm tip) with the listed lot codes and UDI numbers provided in the recall notice.
Review the product's part number and lot codes to confirm if it matches the recalled models listed in the recall notice.
Medtronic has identified that certain lots of the VCLAS laser diffusing fibers were not tested at intended laser power levels due to calibration issues in testing equipment, which could lead to low laser energy output or fiber burnout.
The recalled models are Visualase Cooled Laser Applicator System 3mm tip (part number 9735559), 10mm tip (part number 9735560), and 15mm tip (part number 9735561) with specific lot codes and UDI numbers listed in the recall notice.
No immediate stop is required as the hazard is low risk. However, you should check your product details against the recall list to confirm if it is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2501-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2501-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
