Synaptive Medical Inc recalls BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can nav…

Recall date

October 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0470-2019

FDA classification

Class I

Brand / firm

Synaptive Medical Inc

Sold / distributed

Worldwide - US Nationwide Distribution and the country of Canada

Why it was recalled

This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.