Z-1561-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 11, 2022
- Termination Date
- October 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 (112 US, 6 OUS)
Product Description
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
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 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
Code Information
UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017