Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a severity score of 5 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Navigation, Inc. is recalling the StealthStation Cranial and Synergy Cranial software, specifically the Optical Pocket Guide and Biopsy Needle Kit accessories. The recall involves 5,487 impacted systems distributed across the United States and numerous international locations.
The recall was initiated because of an incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software. This error resulted in the biopsy of healthy tissue. The affected software versions include 2.2.0, 2.2.5, 2.2.6, and 2.2.7 for Synergy Cranial, and 3.0.0, 3.0.1, 3.0.2, and 3.1.0 for StealthStation S7 Cranial.
Healthcare facilities and users of these systems should contact Medtronic Navigation, Inc. for instructions on how to resolve the issue. The agency has classified this as a Class I recall.
The recalled product
- Product
- StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 5,487
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 (7)
- 2.2.5
- 2.2.6
- 2.2.7 Synergy Cranial 9735585 3.0.0
- 3.0.1
- 3.0.2
- 9733763
- 9731975
Distribution
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