Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard
Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.
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 involves a risk-of-harm product where the device physically bends in an MRI field, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Medtronic Navigation, Inc. is conducting a voluntary field action for the Visualase Body Accessory Kit (PN 020-3000) and Visualase Visualization Stylets. The recall involves 100 total units, specifically Lot number 151591. These devices are labeled sterile and are used during Visualase laser ablation procedures to improve catheter stiffness and MRI visualization.
The recall is being issued because the Visualization Stylet, which is constructed of titanium, pulls and/or bends toward the magnetic field when placed in a magnetic resonance imaging (MRI) system. This behavior presents a safety hazard during the intended use of the device.
The affected products were distributed worldwide, including in the United States (California, Georgia, Florida, and Texas) and internationally to Australia. Users of these devices should stop using the affected stylets and contact Medtronic Navigation for further instructions.
The recalled product
- Product
- Visualase Body Accessory Kit PN 020-3000. 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…
- 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 151591
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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