Synapse Biomedical Inc FDA Recalls

2 recalls on file across devices, 1 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.Class IJul 11, 2022Due to a defect identified on the EPG controller printed cir	Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrad	Class IDevices	Jul 11, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx Class IIIMay 31, 2022Firm has revised labeling to consistently call out storage c	Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to	Class IIIDevices	May 31, 2022