Stimwave StimQ Peripheral Nerve Stimulator Recalled for Non-Functional Component
Stimwave Technologies is recalling 2,197 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, and the hazard involves a non-functional component not referenced in labeling, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
Stimwave Technologies Inc. is recalling 2,197 units of the StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-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 devices are distributed worldwide, including in the United States and various countries in Europe, South America, Africa, and the Middle East. The recall covers specific serial numbers for the STQ4-SPR-B0 US and STRQ-SPR-B0 EU models.
Consumers should check their device serial numbers against the list provided in the official recall notice. If the device is affected, users should contact Stimwave Technologies Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-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 — Pain Management
- Affected units
- 2,197
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-SPR-B0 US
- Serial Numbers: 211668-1
- 211668-10
- 211668-11
- 211668-12
- 211668-13
- 211668-14
- 211668-15
- 211668-16
- 211668-17
- 211668-18
- 211668-19
- 211668-2
- 211668-20
- 211668-21
- 211668-22
- 211668-23
- 211668-24
- 211668-25
- 211668-26
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 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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