Medtronic issues Class 1 recall of cranial software: 5 things to know

Written by Laura Dyrda | January 09, 2019 | Print  |

Medtronic recalled the Synergy Cranial Software and Stealth Station S7 Cranial Software.

Five things to know:

1. The company issued a Class 1 recall, indicating use of the device could cause serious injury or death.

2. Medtronic issued the recall of the software after users reported inaccurate information displayed during biopsy procedures. The inaccuracies may result in serious or life-threatening patient harm, according to the report.

More specifically, the company reported: "During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain. In the event this software defect occurs, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels."

3. The device was manufactured and distributed from Aug. 31, 2011, to Oct. 16, 2018, and Medtronic sent an urgent medical device correction notice to customers Sept. 21, 2018.

4. On Dec. 28, the company reported it would continue to follow up with customers about the urgent medical device correction throughout the following months.

5. The software is used with Medtronic's StealthStation surgical navigation system, which is designed to provide 3D images of the patient's brain to navigate surgical tools and implants intraoperatively.

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