Medtronic Issues Class I Recall For Its Surgical Navigation Software Due To Glitch

Medtronic Plc MDT recalled StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make the surgical plan data shift location(s) after the initial test is changed. 

The glitch can cause the surgical plan data to be in an unintended location for the surgery.

The FDA deemed the recall of StealthStation S8 software Class I, the most serious kind.

The use of the affected product may cause serious adverse health consequences, including death. 

There have been no reported injuries. There have been no reports of death.

Also Read: Medtronic Recalls Certain Heart Failure Devices Citing Risk Of Low, No Energy Output During High Voltage Therapy.

This recall — a correction, not a product removal affects 2,109 devices distributed in the U.S. between Jan. 7, 2022, and Oct. 2, 2023. Medtronic initiated the recall on Sept. 27, 2023.

The StealthStation System is used for any medical condition in which stereotactic surgery may be appropriate. 

This system keeps track of where surgical tools are about a patient's anatomy by using images of the patient. 

As the surgeon works, the system shows where the tool is on these images and models the surgeon picked. 

Before surgery, the surgeon can plan the path for the tools and see how they should move. During surgery, the software helps the surgeon see if the actual tool position matches the plan, guiding them along the right path. 

These tools help find body parts during brain surgery, whether open or less invasive. 

Price Action: MDT shares are down 0.46% at $81.69 on the last check Wednesday.

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