Oberlin, OH, United States
Synapse Biomedical Inc recalls
2 recalls recorded since 2018, most recently on 11 July 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 11 July 2022
- Terminated
- 24 October 2023
- Reason
- Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.
- Distribution
- distribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and SC; Germany and Kuwait. ***Updated 3/28/23 - Product was not distributed to United Arab Emirates. Product was distributed to Kuwait.*** Updated 9.14.23 - 1 patient in Germany, 1 patient in the Czech Republic, 1 distributo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1561-2022
- NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Terminated Class III Medical devices
- Recall started
- 31 May 2022
- Terminated
- 11 April 2024
- Reason
- Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).
- Distribution
- Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1393-2022
- NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx D
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.