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.
More articles on orthopedic devices:
Zimmer Biomet, NuVasive, Alphatec & more: 11 device company notes
Stryker recalls spine device: 5 things to know
Zimmer Biomet CEO Bryan Hanson: Growth in 2019
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.