Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 1,424 StimQ Peripheral Nerve Stimulator units 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 source text describes a non-functional component not referenced in labeling without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Stimwave Technologies Inc. is recalling 1,424 units of the StimQ Peripheral Nerve Stimulator System (PNS), including models FR4A-TRL-BO US and FR4A-TR-BO. The recall was initiated because the product contains a non-functional component that is not referenced in the product labeling.
The affected devices are 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 recall covers units 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. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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 — Pain Management
- Affected units
- 1,424
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. FR4A-TRL-BO-US
- Serial Numbers: 211666-1
- 211666-10
- 211666-11
- 211666-12
- 211666-13
- 211666-14
- 211666-15
- 211666-16
- 211666-17
- 211666-18
- 211666-19
- 211666-2
- 211666-20
- 211666-21
- 211666-22
- 211666-23
- 211666-24
- 211666-25
- 211666-26
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 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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