Medtronic recalls stereotactic surgery systems and software versions 3.0+ that may cause inaccurate brain implant lead placement during deep brain stimulation procedures. Affected units include specific models with O-arm imaging systems.
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 system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Medtronic is recalling its Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer that may cause inaccurate lead placement during deep brain stimulation surgery. This could lead to delayed or aborted procedures, additional surgery, or risks to the patient.
The system's auto-registration feature (fiducial-less workflow) with specific imaging systems may not detect minor patient movement during surgery. This can cause inaccurate lead placement in deep brain stimulation procedures, potentially requiring additional surgery or delaying treatment.
Surgical teams using Medtronic's Nexframe Stereotactic System with StealthStation Cranial software version 3.0 or newer during deep brain stimulation procedures are most at risk. Patients undergoing these surgeries with the affected equipment could face complications.
Check for Medtronic Nexframe Stereotactic System models with GTINs DB-2040, 00643169214811, MI-1000, 00643169986763, MI-2000, 00643169986770, or NP-1000, 00613994747877. Affected software versions include StealthStation Cranial 3.0+ with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License used with O-arm Imaging Systems.
Immediately stop using the affected software versions during deep brain stimulation procedures until a fix is implemented.
Reach out to Medtronic for guidance on alternative software versions or procedures to ensure safe surgery.
Software versions 3.0 or newer of StealthStation Cranial with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License.
The Nexframe Stereotactic System and specific O-arm Imaging Systems used with the affected software versions during deep brain stimulation procedures.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1995-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1995-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
