Medtronic recalls StealthStation Cranial and Synergy Cranial Depth Gauges with software versions 2.2.0-3.1.0 that may cause biopsy of healthy tissue due to incorrect depth display.
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Medtronic is recalling StealthStation Cranial and Synergy Cranial Depth Gauges that have a software bug causing the device to show incorrect biopsy depth. This could lead to surgeons accidentally removing healthy tissue during procedures. Affected units include specific software versions and related kits.
The software displays an incorrect biopsy depth gauge, which can cause surgeons to remove healthy brain tissue instead of the intended target during procedures. This happens because the graphical representation in the Guidance View shows the wrong depth measurement.
Surgeons using Medtronic's StealthStation Cranial or Synergy Cranial systems with affected software versions (2.2.0-2.2.7 for Synergy Cranial and 3.0.0-3.1.0 for StealthStation S7 Cranial) are most at risk. The device is used for cranial biopsies and requires precise depth measurement.
Check if your device has software versions 2.2.0-2.2.7 (Synergy Cranial) or 3.0.0-3.1.0 (StealthStation S7 Cranial). The affected units include specific kits and software packages listed in the recall notice.
Verify your software version by checking the device's settings or documentation. Affected versions are 2.2.0-2.2.7 for Synergy Cranial and 3.0.0-3.1.0 for StealthStation S7 Cranial.
Download and install the latest software update from Medtronic to fix the depth display issue. Updates are available for affected versions.
Software versions 2.2.0-2.2.7 for Synergy Cranial and 3.0.0-3.1.0 for StealthStation S7 Cranial are affected.
No, but you should check your software version and update it to the latest version to fix the issue.
The risk is that the device may display incorrect biopsy depth, potentially causing surgeons to remove healthy tissue during procedures.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0552-2019 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0552-2019 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.
