Toronto, N/A, Canada
Synaptive Medical Inc recalls
3 recalls recorded since 2018, most recently on 23 April 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 23 April 2021
- Terminated
- 12 January 2024
- Reason
- Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
- Distribution
- Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1955-2021
- Synaptive Trackable Suction Set Standard and Malleable
Terminated Class II Medical devices
- Recall started
- 26 February 2020
- Terminated
- 10 April 2024
- Reason
- A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1758-2020, Z-1759-2020
- ClearCanvas RIS/PACS
- Synaptive ImageDrive Clinical
Terminated Class I Medical devices
- Recall started
- 9 October 2018
- Terminated
- 12 August 2021
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide Distribution and the country of Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0470-2019
- 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 t
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.