Medtronic recalls Visualase software versions 3.1.1-3.2 for potential MRI-guided laser ablation inaccuracies that could spread thermal energy to surrounding tissue.
Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.
Medtronic is recalling specific versions of its Visualase software (3.1.1 to 3.2) because MRI-guided laser treatments might spread heat to healthy tissue. This could cause unintended tissue damage during procedures.
The software may not accurately measure temperature during MRI-guided laser treatments, causing heat to spread to surrounding tissue without proper detection. This could lead to unintended tissue damage during procedures.
Patients undergoing MRI-guided laser ablation procedures using the affected software versions are at risk. Medical professionals using these software versions for treatment should check their equipment.
Check for software versions 3.1.1 to 3.2 on the Visualase Thermal Therapy System. Product numbers include 9735542 and specific serial numbers listed in the recall notice.
Verify your Visualase software version by checking the device settings or documentation.
Reach out to Medtronic directly for assistance with the recall or to confirm if your software is affected.
The recall states that inaccuracy during MRI-guided laser ablation could cause unaccounted spread of thermal energy to surrounding tissue, potentially causing unintended tissue damage.
Check if your Visualase software version is 3.1.1 to 3.2, and verify the product number (9735542) or serial numbers listed in the recall notice.
Contact Medtronic directly to confirm if your software is affected and to get guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-3251-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-3251-2018 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.
