Medtronic Nexframe Stereotactic System Recalled for Lead Placement Inaccuracies
Medtronic is recalling the Nexframe Stereotactic System and specific software combinations due to potential inaccuracies in deep brain stimulation lead placement.
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 with a risk of harm (inaccurate lead placement, aborted surgery) where specific injuries or illnesses have not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling the Medtronic Nexframe Stereotactic System when used in combination with specific StealthStation software versions and the O-arm Imaging System. This recall applies specifically to procedures utilizing the auto-registration (fiducial-less) workflow during deep brain stimulation (DBS) lead implantation.
The recall is issued because minor patient movement during the auto-registration scan process may not be initially detected by the user or the software. This can result in entry point and lead placement inaccuracies. Potential risks to patients include inaccurate lead placement, delay of surgery, aborted surgery, or the need for additional intervention, such as revision of the lead placement and subsequent imaging.
The affected equipment was distributed worldwide, including in the United States, Austria, Canada, Italy, Romania, Spain, and the United Kingdom. According to the source text, 61 customers purchased the specified combination of equipment that may lead to this error. Healthcare providers should contact Medtronic Navigation for further instructions on managing the recall and ensuring patient safety.
The recalled product
- Product
- Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combi
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 61
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 (20)
- 00643169625549 O-Arm Imaging System GTIN(s): 00763000068073
- 00763000068080
- 00763000068097
- 00763000068103
- 00763000074050
- 00763000074067
- 00763000074074
- 00763000074081
- 00763000074098
- 00763000074104
- 00763000074111
- 00763000074128
- 00763000074135
- 00763000079000
- 00763000079017
- 00763000079024
- 00763000079031
- 00763000079048
- 00763000079055
- 00763000079062
Distribution
Distributed nationwide across the United States.
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