Synapse Biomedical recalls

2 official recalls and safety alerts involving Synapse Biomedical since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Synapse Biomedical or the relevant agency.

1. 2022-08-31
2. US
   Drugs & medicalClass I

   Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

   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…

   FDA · DeviceSynapse Biomedical Incdistribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and…Official notice →
3. 2022-07-27
4. US
   Drugs & medicalClass III

   Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…

   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…

   FDA · DeviceSynapse Biomedical IncDomestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX…Official notice →