Medtronic Visualase Thermal Therapy System Recalled for MR Thermometry Inaccuracy
Medtronic is recalling Visualase Thermal Therapy System software due to potential MR thermometry inaccuracies that may cause unaccounted thermal energy spread during laser ablation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (unaccounted thermal energy spread) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Navigation, Inc. is recalling 161 units of the Visualase Thermal Therapy System, specifically software versions 3.1.1 through 3.2 (Product # 9735542). The recall involves specific serial numbers and UDI codes listed in the agency documentation.
The recall is issued because inaccuracy of MR thermometry during MRI-guided laser ablation procedures may result in unaccounted spread of thermal energy to the surrounding tissue. This defect poses a risk of unintended thermal injury to patients during the procedure.
The affected units were distributed in 34 U.S. states and the District of Columbia, as well as in the United Kingdom, Germany, Switzerland, the Netherlands, and Israel. Healthcare providers and patients should contact Medtronic Navigation for further instructions on how to proceed with the recall and any necessary corrective actions.
The recalled product
- Product
- Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 161
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI #: 00643169655935
- 00643169792890
- 00643169905719
Distribution
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