Stimwave recalls two models of StimQ PNS devices due to a non-functional component not listed in labeling. Affected units include specific US and EU serial numbers for chronic pain therapy devices.
The product contains a non-functional component not referenced in product labeling.
Stimwave is recalling two models of StimQ Peripheral Nerve Stimulator Systems (PNS) because they contain a non-functional component not mentioned in the product labeling. This could lead to improper therapy delivery if the device is used without the correct component.
The device contains a component that does not work as intended and is not described in the product labeling. This could result in the device failing to deliver proper pain relief therapy.
Users of StimQ PNS devices for chronic pain therapy in the US and EU are affected. Those with the specific serial numbers listed are most at risk.
Check if your StimQ device has the model numbers FR4A-RCV-AO (US) or FR4A-RCV-A0 (EU). Look for the specific serial numbers listed in the recall notice for affected units.
Identify if your StimQ device is one of the recalled models: FR4A-RCV-AO (US) or FR4A-RCV-A0 (EU).
Confirm if your device has the specific serial numbers listed in the recall notice for affected units.
The product contains a non-functional component not referenced in product labeling, which could lead to improper therapy delivery.
US model FR4A-RCV-AO with serial numbers 210426-88 to 210426-93 and EU model FR4A-RCV-A0 with serial numbers 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
The recall does not specify a stop-use instruction; the remedy is null, so users can continue using the device if they verify it is not affected.
We’ve drafted a message you can send Stimwave to request your refund or repair — edit it as you like.
Subject: Recall Z-2933-2020 — Stimwave Stimwave Hello, I own a Stimwave that is covered by recall Z-2933-2020 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.
