Recall record at a glance
| Official record | Z-1561-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Synapse Biomedical Inc. |
| Report date | Aug 31, 2022 |
| Recall initiation date | Jul 11, 2022 |
| Quantity | 118 (112 US, 6 OUS) |
| Location | Oberlin, OH, United States |
Official product description
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Why the product was recalled
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 information
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
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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