Medtronic (NYSE:MDT) is recalling select Synergy and StealthStation S7 cranial software used with its StealthStation surgical navigation system over reports of incorrect information being displayed during biopsy procedures in a recall action labeled by the FDA as Class I.
Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The cranial software is intended for use with Fridley, Minn.-based Medtronic’s StealthStation Surgical navigation system and provides detailed 3D images of a patient’s brain to aid in navigation during neurosurgery.
According to the recall notice, during biopsy procedures the software monitor may show that the tip of the surgical tool has not yet reached the planned target, which could prevent the operator from being able to accurately see the location of the tool in the patent’s brain.
In such a case, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient’s healthy tissue, brain or blood vessels, the FDA wrote in its notice.
The recall includes a total of 5,487 systems with both Synergy and Stealth Station S7 cranial software, according to the FDA notice. It affects software systems with model number 9733763 and software versions 2.2.0, 2.2.5, 2.2.6 and 2.2.7 and model number 9735585 and software versions 3.0.0, 3.0.1 and 3.1.0, and is limited to systems manufactured and distributed between August 31, 2011 and October 16, 2018.
Medtronic began notifying individuals about the recall on September 21 last year, and provided steps to mitigate or eliminate risk of damage to healthy tissue during use.
The company advised operators to not set a projection longer than the length of the surgical plan, to follow the cranial software pocket guide and always use the biopsy needle mechanical depth stop and to ensure the navigation instrument tip setting is selected prior to locking trajectory and beginning navigation.
Last month, Medtronic said that it closed the $1.7 billion acquisition of Mazor Robotics (NSDQ:MZOR) and its robot-assisted surgery platform, capping the buyout with the announcement that their first jointly produced product won an FDA nod.