Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 2,444 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, which typically indicates a moderate risk. The specific defect is a non-functional component not referenced in labeling, which is a labeling and functional defect rather than a direct safety hazard like electrical shock or fire, and no injuries or illnesses are reported in the source text.
Plain-English summary
Stimwave Technologies Inc. is recalling 2,444 units of the StimQ Peripheral Nerve Stimulator System (PNS) Model 1. The affected models are STQ4-RCV-A0 US and STQ4-RCV-A0 EU. The recall was initiated because the product contains a non-functional component that is not referenced in the product labeling.
The StimQ PNS 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 electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
The affected units were distributed worldwide, including nationwide distribution in the United States and in countries such as The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic. Consumers and healthcare providers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-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 electrical…
- Manufacturer
- Stimwave Technologies Inc
- Category
- Medical Device — Neuromodulation
- Affected units
- 2,444
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 (20)
- 1. STQ4 RCV A0 US: Serial numbers: 211766-1
- 211766-10
- 211766-11
- 211766-12
- 211766-13
- 211766-14
- 211766-15
- 211766-16
- 211766-17
- 211766-18
- 211766-19
- 211766-2
- 211766-20
- 211766-21
- 211766-22
- 211766-23
- 211766-24
- 211766-25
- 211766-26
- 211766-27
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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