Medtronic Recalls AxIEM Touch N Go Pointer Probe for Accuracy Issues
Medtronic Navigation is voluntarily recalling 111 AxIEM Touch N Go Pointer Probes because they may compromise navigation accuracy during patient registration.
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 medical device where a defect may compromise navigation accuracy, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is conducting a voluntary field action for the AxIEM Touch N Go Pointer Probe, Model Number 9735318. The recall involves 111 devices that were distributed nationwide in the United States. The specific lot number for the affected units is 150626B.
The recall is being issued because the patient registration accuracy of the probe may compromise navigation accuracy when used with the StealthStation System. This potential inaccuracy could affect the precision of the navigation system during medical procedures.
Healthcare facilities and consumers who possess this specific model and lot number should stop using the device and contact Medtronic Navigation for further instructions on how to proceed with the field action.
The recalled product
- Product
- AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 111
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 150626B
Distribution
Distributed nationwide across the United States.
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