NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Check against the official notice below — it lists the full affected range.
Synapse Biomedical Inc. is recalling the NeuRx Diaphragm Pacing System External Pulse Generator (EPG), Part No. 23-0021, due to a defect in the EPG controller printed circuit board assembly. This defect may cause device performance to degrade over time, potentially resulting in serious health consequences including pain, muscle fatigue, decreased breathing effectiveness, irregular heartbeat, cardiac arrest, or unexpected device failure.
A total of 118 devices have been affected by this recall, with 112 units distributed in the United States (in Alabama, Colorado, Illinois, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania, and South Carolina) and 6 units distributed internationally (to patients in Germany and the Czech Republic, and to a distributor in Kuwait). The affected devices have serial numbers ranging from 1900 through 2017. The recall record does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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 distributor in Kuwait Quantity: 118 (112 US, 6 OUS) Lot/code info: UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.