RegWardenFDA facility compliance records
Company

Synaptive Medical Inc

4 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2018: 1 recalls; 2020: 1 recalls; 2021: 1 recalls1201520162017120182019120201202120222023202420252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2021-04-23
    Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
  • Class IITerminated2020-02-26
    A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
  • Class ITerminated2018-10-09
    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…
  • Class IITerminated2015-12-04
    Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Synaptive Medical Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046804-synaptive-medical-inc/

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