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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging…"
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…
- 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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