FDA Medical Device Recalls (openFDA)
Synapse Biomedical Inc: NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
- Recall number
- Z-1561-2022
- Recalling firm
- Synapse Biomedical Inc
- Product
- NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
- Status
- Terminated
- Initiated
- 2022-07-11
- Posted
- 2022-08-22
- Terminated
- 2023-10-24
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On July 11, 2022, Synapse began contacting affected clinical sites where the devices were sent. An initial phone call was made to clinicians that have affected devices at their site or have patients with affected devices. A follow-up email is being sent each of the clinicians that includes a fact sheet for them about the recall, a fact sheet for patients that clinicians can forward to the patients and information about the specific EPGs that have been sent to their site. Patients are asked to register their devices at a webpage specifically developed for the purpose. Replacement devices are available from the manufacturer and arrangements are being made with clinicians and patients to have the devices programmed and delivered to patients as soon as possible. The manufacturer is asking that all devices be returned to Synapse Biomedical for disposal to ensure that no affected devices are inadvertently used at a later time.
- Quantity
- 118 (112 US, 6 OUS)
- 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
- Lot, serial or model codes
- UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OIR
- Firm FEI
- 3005868392
- Firm city
- Oberlin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28