Stimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component
Stimwave Technologies is recalling six StimQ Peripheral Nerve Stimulator Systems because they contain a non-functional component not referenced in product labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a non-functional component not listed in labeling, which fits the criteria for moderate severity without reported injuries or high-risk pathogens.
Plain-English summary
Stimwave Technologies Inc is recalling six units of the StimQ Peripheral Nerve Stimulator System (PNS), Model FR4A-SPR-BO US. The recall is due to the presence of a non-functional component that is not referenced in the product labeling.
The affected units have serial numbers 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, and 210431-93. These devices were distributed worldwide, including nationwide in the United States and in several countries across Europe, South America, Africa, and the Middle East.
The StimQ PNS is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. Consumers and healthcare providers with these specific serial numbers should contact Stimwave Technologies Inc for further instructions.
The recalled product
- Product
- StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an…
- Manufacturer
- Stimwave Technologies Inc
- Category
- Medical Device — Neuromodulation
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- FR4A-SPR-BO-US
- Serial Numbers: 210431-88
- 210431-89
- 210431-90
- 210431-91
- 210431-92
- 210431-93
Distribution
Part of a larger recall action
This product is one of 6 recalled by Stimwave Technologies Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Stimwave Technologies Inc
See all →- ModerateStimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
FDA (Devices) · 2020-09-09
- ModerateStimwave StimQ Peripheral Nerve Stimulator System Recalled for Non-Functional Component
FDA (Devices) · 2020-09-09
- ModerateStimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
FDA (Devices) · 2020-09-09
- ModerateStimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
FDA (Devices) · 2020-09-09
- ModerateStimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
FDA (Devices) · 2020-09-09
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