Synaptive Medical Recalls BrightMatter Guide Software Due to Defect
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric, despite the lack of reported injuries.
Plain-English summary
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software, Product Number SYN-0026, versions 1.5.0, 1.5.1, and 1.5.2. The affected software is used to navigate third-party NICO BrainPath ports by attaching a custom Tracking Array. The recall covers units distributed in the United States and Canada.
The recall was initiated due to a software defect that is triggered under specific circumstances. The defect occurs when a user sets one trajectory with a blue port and another trajectory with a gold port, and then switches between these trajectories during a surgical procedure. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities that have received the affected software should stop using it and contact Synaptive Medical Inc for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- Product
- 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…
- Manufacturer
- Synaptive Medical Inc
- Hazard
- Affected units
- 37
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Synaptive Medical Inc
See all →- HighSynaptive Suction Sets Recalled for Metal Burrs on Tube Interior
FDA (Devices) · 2021-07-07
- HighSynaptive Medical Recalls ClearCanvas RIS/PACS Software Due to Imaging Defect
FDA (Devices) · 2020-04-29
- HighSynaptive ImageDrive Clinical Software Recalled for Mammogram Image Quality Defect
FDA (Devices) · 2020-04-29
- ModerateSynaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance
FDA (Devices) · 2015-12-30
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSynaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance
FDA (Devices) · 2015-12-30
- HighSynaptive ImageDrive Clinical Software Recalled for Mammogram Image Quality Defect
FDA (Devices) · 2020-04-29
- HighSynaptive Medical Recalls ClearCanvas RIS/PACS Software Due to Imaging Defect
FDA (Devices) · 2020-04-29
- ModerateBrainlab Knee Navigation Cutting Block Adapter Base Recalled for Material Error
FDA (Devices) · 2017-01-18
- ModerateNico BrainPath Sheath Recall Due to Incorrect Length Labeling
FDA (Devices) · 2012-08-22
- ModerateNeuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance
FDA (Devices) · 2014-02-19