- Medtronic is recalling the Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of inaccurate information displaying during biopsy procedures. The software defect could cause serious or life-threatening harm to patients, FDA said.
- The company sent an Urgent Medical Device Correction notice to customers on Sept. 21 with steps to eliminate the risk of damaging healthy tissue. The recall was initiated on Sept. 26.
- The recall affects 5,487 devices in the United States that were manufactured and distributed from Aug. 31, 2011, to Oct. 16, 2018.
The software under recall provides detailed three-dimensional images of the brain to help guide neurosurgeons in the placement of surgical tools and implants during surgery. On Dec. 28, the company reported it was continuing to follow up with customers about the correction.
It is being recalled because the software monitor may incorrectly show that the tip of the surgical tool has not yet reached the target and may prevent the neurosurgeon from seeing the correct location of surgical tools in the patient's brain, FDA said. There is a chance that the surgeon could insert the surgical tool too deeply and damage the patient's healthy tissue, brain or blood vessels, the agency said.
To eliminate the risk of damaging healthy tissue, Medtronic's Urgent Medical Device Correction notice advises surgeons to set a projection no longer than the length of the surgical plan, to follow the cranial software pocket guide and to always use the biopsy needle mechanical depth stop. Also, customers should make sure the Navigate Instrument Tip setting is selected before locking the trajectory and using the instrument.
Customers are also instructed to make sure appropriate staff are aware of the issue and to sign a consignee response form attached to the notice and return it to Medtronic.
The device model numbers are:
- 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
- 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0