Z-0470-2019Class I

BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2

Name: Z-0470-2019 BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2
Creator: Synaptive Medical Inc
Published: 2018-10-09
License: https://open.fda.gov/license/

Synaptive Medical Inc / initiated 2018-10-09 / Terminated / root cause: software

FDA source

Synaptive Medical Inc began a recall of 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... on 2018-10-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0470-2019
Classification: Class I
Status: Terminated
Initiated: 2018-10-09
Posted: 2018-11-26
Terminated: 2021-08-12
Recalling firm: Synaptive Medical Inc
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 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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Synaptive Medical sent an Urgent Medical Device Recall letter dated October 9, 2018 via registered priority mail. The letter identified the affected product, problem and actions to be taken until a software patch is released. Customers were requested to complete and return the enclosed Acknowledgement and Receipt form to Synaptive Medical Inc. For questions call 1-844-462-7246.
Quantity in commerce: 37 units
Distribution: Worldwide - US Nationwide Distribution and the country of Canada
Product codes and lots: Serial Numbers: 0063HJ5Y062 00635F48562 00635GTYK32 00638HTZK32 0063G6DRM12 0063CPBRM12 006395Q2Z52 0063J9BD062 00634X19562 0063GN0B562 00637BP9562 0063JTDW462 00638J89562 006360JV462 0063F1Q2Z52 0063FGWYK32 006384WYK32 00635YH8562 0063C2SKH72 00635NWPK12 0063DKWYK32 006358Q2Z52 0063HM0B562 0063DZPGP12 00634BBD062 00636L48562 0063DD8GP12 0063HCZ1Z52 006318XYK32 0003CZDRLC2 0063GLD6562 0063HRZYK32 006317B8562 006348M5562 0063HGTYK32 0063FHXY062 00634DBD062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0470-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0470-2019	Class I	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-26

Product code HAW

K153281Class IIBrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. / cleared 2016-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)