The Recall Desk

Manufacturer

Synaptive Medical, Inc.

5 recalls in our database name Synaptive Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2021-07-07

Of the 5 recalls from Synaptive Medical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • HighFDA (Devices)·Z-1955-2021·2021-07-07

    Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior

    Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.

    Product
    Synaptive Trackable Suction Set Standard and Malleable
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-0470-2019·2018-12-05

    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.

    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 co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2016·2015-12-30

    Synaptive Medical BrightMatter Navigator System Recalled for RF Emission Exceedance

    Synaptive Medical is recalling eight BrightMatter Navigator Systems because they exceeded radio frequency emission limits. The devices were distributed to facilities in five US states.

    Product
    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer a
    Category
    Medical Device
    Distribution
    5 states