Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Recall Z-3251-2018 · Posted None
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Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2018-06-01
Date Terminated2022-02-02
Product Quantity161
Reason for Recall
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.
Firm Action
On 06/01/2018, Urgent Medical Device Correction letters and Consignee Response Forms were mailed to customers via overnight mail service. Customers were provided with additional information intended to supplement the system manual and instructed to call the firm at 1-888-826-5603 if they had any questions.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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