medical Class I Updated 2022-08-31

Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Gen

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, SC
Lot/Code Info: UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
View official government recall

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