Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction
Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.
What this means for you
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 involves a risk-of-harm product where the device bends or pulls in an MRI field, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Medtronic Navigation, Inc. is conducting a voluntary field action for Visualase Visualization Stylets (PN 020-2301) and the Visualase Body Accessory Kit. The recall involves 100 total units, specifically Lot number 151481. These devices are constructed of titanium and are used during Visualase laser ablation procedures to improve catheter stiffness and MRI visualization.
The recall is being issued because the Visualization Stylet pulls and/or bends toward the magnetic field when placed in a magnetic resonance imaging (MRI) system. The devices are labeled as sterile and are packaged in Tyvek pouches within a cardboard box.
The affected products were distributed worldwide, including in the United States (California, Georgia, Florida, and Texas) and internationally to Australia. Users should stop using the affected devices and contact Medtronic Navigation for further instructions.
The recalled product
- Product
- Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visua
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 100
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 (1)
- Lot number 151481
Distribution
Part of a larger recall action
This product is one of 2 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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