Stimwave recalls StimQ Peripheral Nerve Stimulator System Model FR4A-TRL-AO US due to a non-functional component not referenced in product labeling. Affected units include specific serial numbers listed in the recall. No remedy is provided in the official notice.
The product contains a non-functional component not referenced in product labeling.
Stimwave is recalling its StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US because it contains a non-functional component that isn't listed in the product labeling. This issue doesn't pose an immediate safety risk but could lead to improper function of the device.
The device contains a component that is not referenced in the product labeling, which means it may not function as intended. This could lead to improper pain relief therapy but does not pose a risk of injury or damage to the user.
Users of the StimQ PNS Model FR4A-TRL-AO US with the listed serial numbers are affected. Individuals using this device for chronic pain therapy may be at risk of improper function due to the non-functional component.
Check if your StimQ PNS Model FR4A-TRL-AO US has a serial number listed in the provided range (e.g., 211662-1 to 2B11880-9). The device is used for peripheral neural stimulation to provide therapeutic relief for chronic pain.
Identify your device's serial number and compare it to the list of affected serial numbers provided in the recall notice.
No, the device does not pose an immediate safety risk. The issue is that it contains a non-functional component not referenced in product labeling, which could lead to improper function but not injury.
The official recall notice does not specify a remedy. You should check your serial number against the list provided and contact Stimwave for further guidance.
Your device is affected if it has a serial number listed in the provided range (e.g., 211662-1 to 2B11880-9).
We’ve drafted a message you can send Stimwave to request your refund or repair — edit it as you like.
Subject: Recall Z-2929-2020 — Stimwave Stimwave Hello, I own a Stimwave that is covered by recall Z-2929-2020 from Stimwave. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
