NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Summary
The FDA issued a Class I for NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part N by Synapse Biomedical Inc. Reason: Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mo.
Details
Source
Device Recall
External ID
Z-1561-2022
Action Date
2022-08-31
Status
Terminated
Category
device
Product Description
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Lot/Code Info: UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
Quantity Affected: 118 (112 US, 6 OUS)
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-11
Company
Oberlin, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synapse Biomedical Inc has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Synapse Biomedical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synapse Biomedical Inc have FDA actions?
Synapse Biomedical Inc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1561-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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