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U.S. Department of Health and Human Services

Class 1 Device Recall NeuRx Diaphragm Pacing System (DPS) External Pulse Generator (EPG)

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 Class 1 Device Recall NeuRx Diaphragm Pacing System (DPS) External Pulse Generator (EPG)see related information
Date Initiated by FirmJuly 11, 2022
Date PostedAugust 22, 2022
Recall Status1 Terminated 3 on October 24, 2023
Recall NumberZ-1561-2022
Recall Event ID 90626
HDE NumberH100006 H070003 
Product Classification diaphragmatic/phrenic nerve laparoscopically-implanted stimulator - Product Code OIR
ProductNeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Code Information UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
Recalling Firm/
Manufacturer		 Synapse Biomedical Inc
300 Artino St
Oberlin OH 44074-1263
For Additional Information ContactDavid Mahilo
440-774-2488 Ext. 138
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce118 (112 US, 6 OUS)
Distributiondistribution 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE DatabaseHDEs with Product Code = OIR
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