Recall due to software defect now corrected
On Tuesday, November 27, the US Food and Drug Administration assigned a Class 1 designation to Synaptive Medical’s voluntary recall of BrightMatter™ Guide due to a software defect discovered under routine testing in our facilities.
Health Canada classified the same software defect as a lower risk Type II recall.
We confirm that the defect has been successfully patched and resolved at all affected customer sites in North America as of Wednesday, November 21, 2018. To date, there have been no known patient or user injuries related to this isolated issue.
Other Synaptive Medical products, such as BrightMatter Plan and Modus V™, were not affected by this recall, nor was SurfaceTrace, a feature of BrightMatter Guide.
On Tuesday, October 9, we notified our customers and clinical team of the potential impact of a software defect that may manifest when BrightMatter Guide is used with NICO BrainPath ports under certain circumstances. Through this customer notification, we provided several interim measures to effectively detect and resolve the defect’s occurrence while continuing to use the system.
In addition, following the FDA’s recommendation, we advised affected Guide users that they should not switch between gold and blue NICO BrainPath ports when used within the same procedure as BrightMatter Guide.
In tandem with these interim measures, our team also worked on a software update to remedy the defect and resolve the potential risk it presented to patients. That software update has now been released and applied to all affected systems in Canada and the United States. While the interim measures remain good practice, the software no longer displays the behavior that required them.
Synaptive remains committed to prioritizing patient safety. We take pride in the speed in which we responded to contain and correct this issue to get the best and safest products out for our customers and their patients.
Should you have any questions or concerns about this voluntary recall, we invite you to contact us at 1-844-462-7246 and request to speak with our Communications team.