Medical DeviceJul 7, 2021
Synaptive Trackable Suction Set Standard and Malleable recall — FDA Z-1955-2021
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Class IIFDA: TerminatedSynaptive Medical Inc.
Recall history in this database
Classification mix: Class II: 1, Class I: 1.
Medical DeviceDec 5, 2018
Synaptive Medical BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and recall — FDA Z-0470-2019
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…
Class IFDA: TerminatedSynaptive Medical Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Synaptive Medical Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.