Stimwave recalls StimQ PNS Models FR4A-SPR-BO US due to a non-functional component not listed in product labeling. Affected units have specific serial numbers.
The product contains a non-functional component not referenced in product labeling.
Stimwave is recalling its StimQ Peripheral Nerve Stimulator System models FR4A-SPR-BO US because the device contains a non-functional component not mentioned in its labeling. This could lead to improper therapy delivery if the device is used without the correct component.
The device has a component that doesn't work as intended and isn't described in the product labeling. This could mean the therapy might not work properly, but it doesn't cause immediate harm or injury.
Users of the StimQ Peripheral Nerve Stimulator System for chronic pain therapy are affected. Those with specific serial numbers listed in the recall are most at risk.
Check if your StimQ device has the model FR4A-SPR-BO US and serial numbers 210431-88 through 210431-93. The product is used for chronic pain therapy via electrical stimulation.
Verify your StimQ device model and serial number against the list provided in the recall.
The product contains a non-functional component not referenced in product labeling, which could affect therapy delivery.
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US with serial numbers 210431-88 through 210431-93.
The recall does not specify a stop-use action; the device may still be used but with potential therapy delivery issues.
We’ve drafted a message you can send Stimwave to request your refund or repair — edit it as you like.
Subject: Recall Z-2931-2020 — Stimwave Stimwave Hello, I own a Stimwave that is covered by recall Z-2931-2020 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.