Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 13 StimQ Peripheral Nerve Stimulator units because they contain a non-functional component not listed in the 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, but the source text describes a non-functional component and labeling discrepancy without reporting any injuries, illnesses, or specific safety hazards like electrical shock or fire. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues where no harm has been reported.
Plain-English summary
Stimwave Technologies Inc is recalling 13 units of the StimQ Peripheral Nerve Stimulator System (PNS). The affected models are the FR4A-RCV-AO US and FR4A-RCV-A0 EU. These devices are used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin.
The recall was initiated because the product contains a non-functional component that is not referenced in the product labeling. The specific serial numbers for the US model are 210426-88 through 210426-93. The specific serial numbers for the EU model are 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, and 210425-7.
The affected units were distributed worldwide, including nationwide in the United States and in several countries across Europe, South America, Africa, and the Middle East. Consumers should check their device serial numbers against the list provided by the manufacturer and contact Stimwave Technologies for instructions on how to proceed.
The recalled product
- Product
- StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed…
- Manufacturer
- Stimwave Technologies Inc
- Category
- Medical Device — Neuromodulation
- Affected units
- 13
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 (15)
- 1. FR4A-RCV-A0 US
- Serial Numbers: 210426-88
- 210426-89
- 210426-90
- 210426-91
- 210426-92
- 210426-93
- 2. FR4A-RCV-A0 EU
- Serial Numbers: 210425-19
- 210425-22
- 210425-23
- 210425-6
- 210425-63
- 210425-64
- 210425-7.
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 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 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
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