Synapse Biomedical Inc: Medical Device Recall in 2022 - (Recall #: Z-1561-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: July 11, 2022

Date Posted: August 31, 2022

Recall Number: Z-1561-2022

Event ID: 90626

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.

Status: Terminated

Product Quantity: 118 (112 US, 6 OUS)

Code Information:

UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated