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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81317

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 09, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Synaptive Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0470-2019
Recall number
Z-0470-2019
Initiated
October 09, 2018
Classification
Class I
Status
Terminated
Recalling firm
Synaptive Medical Inc
Quantity
37 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide - US Nationwide Distribution and the country of Canada